June 29, 2016 • 39 mins
Biosimilar drugs have the potential to change the medical landscape. We talk about what biosimilar drugs are and their pros and cons.
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Episode Transcript
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Speaker 1 (00:00):
Brought to you by Toyota. Let's go places. Welcome to
Forward Thinking. Hey there, and welcome the Forward Thinking, the
podcast that looks at the future and says, no pills
gonna cure my ill. I got a bad case of
(00:20):
loving you. I'm Jonathan Strickland, and I'm Joe McCormick. And Jonathan,
you're back. I am back, but you might notice this
is a really appropriate thing for us to cover today
because my voice is dying. I've had I've been fighting
off a little bit of a cold for it ever
since I got back. Did you get cruise crud? Either
(00:41):
cruise cut crud or the European boogie flu? I don't know.
I mean it was. I had a great time. I
sailed around the British aisles. We told the listeners many
untrue stories or might not be dead. Yeah, I got
a lot of concerned tweets that was dead. I don't
think we said Dad was heard. It was almost definitely.
(01:02):
Didn't tell anyone you were down. That's good. So we
may have mentioned Quidditch made dismissive comments about France. I was,
in fact at a castle where they did shoot some
of the Quidditch scenes from Harry Potter on Castle Historic
Comma The Percy's I was there for Hotspur, my wife
was there for Harry Potter. Anyway, none of that has
(01:23):
anything to do with what our topic is today, but
the fact that I was talking about feeling a bit
under the weather does kind of because we're talking about biosimilars,
a type of drug, and you may have heard this term,
and some of you may even be very familiar with it,
but I to to just be honest, I had heard
the term, but didn't really understand it until we started
(01:46):
doing research for this episode. I think I think I
knew nothing about it. Yeah, I think that I completely
misunderstood it. We were talking right before we started up
about how it was sort of a difficult topic to
to wrap our heads around, partially because some of the
parding about it is a little bit confused itself. Yeah,
it's not misleading, at least not clear right or just
(02:08):
not going into depth. I think I didn't really understand
before the difference between biosimilar drugs and generic drugs, right
and and and biosimilar drugs been in the in the
press a little bit lately because of some stuff floating
around the f d A hopefully not literally that that
that has to do with with the way that these
(02:29):
drugs are are going to be regulated in maybe the
near future, uh, maybe a little while from now, but
but yeah, So, so there is a distinct difference between
biosimilar drugs and generic drugs. And let's let's let's figure
that out. Let's lay down these these ground definitions, right,
So first, let's just start with just the basic idea
of what is a drug. Let's manufacture some drugs. Wow
(02:53):
this episode with Downhill in a hurry. All right, So
the drug is, at its most basic level, some sort
of molecule that has a pharmacle logical effect on something organic.
And we are going to talk about drugs for humans
because that's what we are. I mean, I don't want
to speak for all of us. I'm not I am
definitely not almost sure. I'm definitely not a reptilian. I'm
(03:14):
not going to not say that I'm a reptilian. Okay,
I'm mostly interested in drugs for wizards. Can we talk
about those. We'll get back to quidditch later. So typically
when we talk about drugs, we're talking about ones that
were designed through chemistry in a lab. That's the majority
of the drugs we use today are of that category.
(03:35):
Not all of them are. Some of them are biologic
as opposed to, uh the the chemical approach, but we'll
get into that. So when a pharmaceutical company develops a drug,
it's really trying to build a molecule meant to have
a particular effect on the person taking the drug, whether
it's to fight a particular illness or alleviate symptoms or
something along those lines. It's it's it's meant to make
(03:58):
some kind of chemical change in your body in order
to do a stuff right. Right, And typically the active
ingredient is the drug itself, but an active ingredient is
not the only ingredient in most drugs. You tend to
have a lot of other stuff that is there. Maybe
it's to act as almost like a catalyst. Sometimes it's
just a filler to a carrier system to get the
stuff into your stuff. Sure, yeah, so you we in
(04:21):
the getting over into the generic drug area. UM, you
would first call one of those drugs like the main
one that has already been developed by a company. It's
been uh filed with intellectual property, so it has its
own proper name that does not necessarily relate to any
of the chemicals inside that drug. It's usually a pun
(04:41):
of some kind. Yeah, yeah, you get some or you'll
just get like it will sound vaguely scientific, but then
you realize that that's just a brand name that someone
came up when they said this is testing. Well, yeah,
maybe it would help to have an example to continue
through this. Let's do aspirant. I was gonna make one up. Okay,
go go ahead, make one up. Well, let's say you
invent a small molecule drug that causes rapid balding for
(05:04):
people who don't like to have haircuts. You know, they
just don't want to deal with it. Advanced rapid balding.
And I feel like I'm being attacked in this episode
talking about I feel like I'm I've been advanced rapid
balding for years. So this drug, the brand name version
of it that is patented by the original drug innovator,
(05:25):
is called Scalp Extra. Scalp Extra, that's that's the that's
the brand name, brand name. Yeah, so there's an active
ingredient in scalprexa. Uh what Scalp extra. Sorry, Um, well
I don't need it, obviously, I've already it's it's worked
on me. So Scalp Extra is the brand name. What
(05:47):
is the active ingredient? Makes something else up? Uh, it's sugar.
I don't know what it is. It's a chemical, I
don't I know, But you can just make up a
name for a chemical. Two for the purposes of this,
It's called cubal hydride. Alright. Cubal hydride is the active
ingredient in scalp extra. Alright, cubal hydride. So, uh so
(06:10):
in the in the terms of generic drugs, you would
have scalpexor, which is your reference drug, all right, and
then cubal high what was it? Cub hyd cuble hydride
is your is your actual active ingredient that becomes the
generic term for that drug, all right. So generics are
(06:31):
are drugs that have the same active ingredient as a
brand name, and they are meant to have the same
pharmacological effect as the reference drug that brand name drug
Scalp Extra in this in this example that we have created.
So if they're the same thing, in what sense is
the generic different? Well, it has basically just to do
with intellectual property law, right pretty much. Yeah. Yeah, So
(06:53):
after the patent lifetime of the original patent on that
drug expires for the drug innovator, then another company can
come along and say, well, I want to make this
same drug, but basically the only thing they can't do
is call it by the same name. So and and
frequently the some of the non active ingredients will be different, right,
(07:14):
which also partially explains why if you've ever noticed that
sometimes generic drugs don't work exactly the way that that
that a brand name drug does. It could be a
placebo effect, or it could be a genuine chemical difference
in the way that the drug is entering your system.
Right there. There can be cosmetic differences to it can
be shaped, your color different, well, it might be a
(07:34):
pill versus like the gelatine capsule type stuff. It all depends, right. So,
the in the United States, the Food and Drug Administration
has very specific rules for generic drugs and says that
generic drug must be identical or within a range of
bioequivalence to the reference drug. So it has to be
that way. Now, biosimilar drugs are different from this. They
(07:56):
are not meant to be chemically identical to a reference drug.
You still do have a reference drug, so they're intended
to produce medicinal effects that they are. One, they're not
created through chemical synthesis, and the molecular structure is much
larger and more complex than traditional brand name drugs or generics.
(08:16):
So you first start off with a biologic therapy of
some sorts. So this is this is similar in a
way to the reference drug we talked about a second ago,
the brand name drug, but in this case it's biologically
derived UM and biosimilar is meant to replicate the effects
of the reference drug, the biologic therapy, but it doesn't
(08:39):
have to at all molecular lee resemble that reference drug,
right because Okay, So, biological therapies are products that are
made from biological sources, their extractions from cells or tissues
or or stuff that is made inside cells and tissues. Uh.
They can also be called biopharmaceuticals or biologics, and they
(08:59):
include things like like like hormone therapies, vaccines, blood components,
gene therapies, anti venom or antitoxin, insulin, stuff like that, Right,
And so keep in mind we're we're talking about both
generics and biosimilars are supposed to achieve the same results
as their references. But in the case of generic drugs.
(09:20):
When you break it down chemically, it is for all
intents and purposes, identical to the reference. It does the
same thing because it is the same right, right, It's
it's a chemical structure, um and and biologic therapies are
are more complicated because of a the way they're produced
and be the stuff that they're made of. Right. So
if you want to have like an analogy that's not
(09:40):
drug related, you could say that if you look at
a catapult and a giant sling shot, they both can
propel an object a very great distance. They do it
in slightly different ways, but the end result is the
same and they don't physically resemble one another, right, So
you could if you could design it in such a
(10:01):
way where some of the same elements some of the
same elements, which is true with biosimilars as well. So
that's why I wanted to say, like again, you've got
to think of biosimilars as being an attempt to create
the same effect as some other reference, but it isn't
identical to the reference. Not only that, but if you
have two different companies trying to make biosimilar drugs, so
(10:24):
you've got your reference biological therapy, right, that's created by somebody.
You have two other companies that want to make a
biosimilar therapy using that first one as its reference. The
two biosimilar therapies won't resemble one another either. They will
resemble the they won't physically. Yeah, I mean, I mean
because because you have to reverse engineer. Because we'll look
(10:48):
into this in a minute. But but but the way that
these things are patented, Uh, people don't or companies rather
don't have to write down everything about their process. They
just they just patent the end result and so um so,
so when when another company comes along and tries to
reverse engineer that process, then what they come up with
might be wildly different. Yes, And so, as we've already
(11:12):
alluded to, making these things is complicated. I mean, you're
you're talking about like almost like growing a drug as
opposed to synthesizing one through chemistry. And because of this,
the whole process requires a lot of precision and expertise.
It is not an easy thing to do. It's not
easy to produce it on a mass scale either. So
(11:34):
for uh, that reason, a lot of biologic therapies tend
to be incredibly expensive because it's not it's not easy
to do, and it's not easy to do on a
big scale. So in order to balance that out, companies
end up charging more for their various biologic therapies. It's
not true in every single case, but in a lot
of cases it is, so there was there's hope that
(11:57):
biosimilars can help bring that cost down own. But we'll
get into how that gets a little complicated and just
a little further um. Now, the other issue we need
to talk about is the idea of testing drugs. We've
talked about drug testing and clinical trials in previous episodes.
This is a pretty exhaustive process for good reason. You
(12:18):
want to make certain that the drug that you are
developing is efficacious and it is not toxic. Without this process,
we would be back in the era of patent medicine, right, yes,
And we'll talk about patent medicine pretty soon too. Patent
medicine and patented medicines yet more confusing terminology. But that
is an excellent, excellent point. I mean, we would if
(12:40):
you go, if you think about it, without that clinical testing,
you're getting down to, uh, the idea that that a
company could sell a drug claiming that it has an
effect without having to prove it or even make certain
that it isn't it self harmful to people, and we
don't want that. That's why we have organizations like in
(13:01):
the US, the Food and Drug Administration to make sure
that companies are following very specific guidelines to not cause harm.
So with generic drugs, the testing is a little more
simple because you've already got a reference drug that is
chemically identical to the generic drug, at least for the
(13:23):
active ingredient, So you already know what it does to people, right, Yeah,
it's already it's already passed through clinical trials before it
could ever go onto the market. Now that doesn't that
doesn't mean generic drugs get a free pass and just
immediately go straight to store shelves, but it does mean
that a lot of that work has already been done,
and so the clinical trials are usually smaller and less exhaustive.
(13:45):
I would say that's probably also a reason why generic
drugs are cheaper. Well, yeah, because as much to get
to the stores, right, yeah, I think they can be
more profitable little at a lower cost. Right, And and
they're also cheaper because at that point it's a longer monopoly, right,
you can't. Now, they can undercut, right, they can undercut
(14:06):
the the the main proprietor of said drug. Well, biosimilars
are totally different, right, because we've just said a biosimilar
drug can be completely structured in a different way than
it's reference drug. Um it's supposed to do the same
thing pharmacologically, but structurally it could be very different. Because
it could be very different, then there's the question of well,
(14:27):
will this have different symptoms, will be have a different
toxicity level than say, the reference drug does. It has
to undergo much more extensive clinical trials than generics tend to.
So that is another reason why the cost difference between
a biosimilar drug and the reference drug may not be
as great as you would see in generic drugs, because
(14:51):
you still have to undergo this incredibly exhaustive testing for
good reason. I'm not I'm not suggesting that that's a
bad idea. Sure, yeah, yeah, but but the but the
market is still in play. You'll still have the effect
of um of companies attempting to undercut each other's prices. Right,
The question is just how far lower can they go?
Considering the fact that the UM the investment in biosimilars
(15:13):
is generally speaking higher than it is to go into
the business of designing generic drugs, or not designing but
producing generic drugs. So let's let's talk about this idea
of copyrights and patents because it does play directly into
generics and biosimilars. It's not all science and technology, it's
also economics and intellectual property. Um. So when you start
(15:35):
looking at large scale drug manufacturing, you have to go
all the way back to the Revolutionary War here in
the United States. That's when uh Andrew Craiggie begin established
a manufacturing facility in Pennsylvania and he became the first
Apothecary General of the United States. General. We don't have
one of those anymore, we know he's entitled though. Yeah
(15:59):
we got got rid of got rid of that shortly
after the Alchemist General. Um. But so by seventeen inventors
were starting to file patents in the United States for
medical devices and medicines. By the mid eighteen hundreds, companies
began to form around new manufacturing practices, which at the
time that was actually more important than the medicines themselves.
(16:21):
The way you manufactured them became much more important than
whatever it was you were making uh. And the reason
for that is that in the United States we were
really dependent upon other parts of the world to actually
research and develop medicines. Then what would happen is those entities,
mostly in Europe, would essentially license the medicines into the
(16:45):
United States where we could produce them here, but it
was because somewhere else that's where that's where they were
being developed. So it was like an interesting thing to
look at that that we weren't really developing drugs in
the US at that time, we were simply producing them
based upon the work people in Europe were doing. So
that actually became a bit of a problem because well
(17:08):
by the end of the nineteenth century, German manufacturers were
holding most of the patents around major medicines in the
United States UM and in fact, there were subsidiary companies
in the U S subsidiaries of those German companies that
were producing the drugs here in the US, and they
didn't have the full recipe. Like it's like you would
get a jar with you know ingredient X, and then
(17:30):
you would you would go ahead and do the mixture
as right, but you didn't know what was in ingredient X. Um,
so it was kind of interesting that it was being
kept as a sort of a trade secret, so even
though it was being produced in the US, people in
the U s didn't know what was going into it.
But okay, so we're we're coming out of the eighteen
hundreds going into the nineteen hundreds, and lots of these
(17:53):
companies were from Germany. Yeah. Yeah, so you're you're you're
getting your you're thinking about like what have ends around oh,
nineteen fourteen too, that you know, are somewhere around that
range where you know, some conflict is happening in Europe.
They they're entering into a you know, the war to
end all wars. Yeah, except you know, of course it
didn't end all wars so much so that no one
(18:16):
at the time called it World War One because they
were all very optimistic. Um though, at any rate, world
War one happens, and because it happens, it ends up
creating a problem where the US is not able to
access those drugs, those medicines that were coming from Germany anymore.
(18:38):
The United States was trying to find ways to make
certain that it wasn't providing financial support to Germany during
World War One. Sure, I'm sure that also some trade
routes were a little bit disrupted by by the little
bit seating. Yeah, so there was actually a lot past
that that basically let Americans get around this, this entire thing. Yeah. Yeah,
(19:00):
you get to a point where you're like, well, how
do we how do we deliver upon medicines? How do
we do this in this time of tribulation? What what
are our options? The United States government in nineteen seventeen
passes the Trading with the Enemy Act and then actually
allowed companies to produce products that were otherwise protected by
patents if those patents were held by individuals or companies
(19:20):
and enemy states. Its invenient. So right, like, your intellectual
property doesn't count if you are at war with the
United States and such a fascinating precedent. I love that. Yeah,
it's It's also the way I live my life. When
I get into a spat with somebody, I'm just like, well,
their ideas are no longer relevance, and I can I
can take whatever they had. Well, now, so does this
(19:44):
also mean that if somebody like physically assaults you, you
can plagiarize their novel? I mean, that's how princip If
that's accurate then I'm gonna I'm gonna go to go
out to the writer events and like just start picking
fights with people. So like, oh man, what are you
gonna do? Punch me, I'm gonna steal your short story.
(20:06):
I think you're gonna need to be a little more
specific with your wording because technically you can do that.
You just can't get away. Uh. Yeah, you can't get
away with it. But you you you could physically do
that thing. Um. So we get through World War One, uh,
and then we started getting into a new thought process
in the United States. And this is what allows generic
(20:28):
drugs to really become a thing. Back in the nineteen twenties.
It's a little company called Bayer, going back to aspirin. Uh.
They were writing high on the headaches of the world,
selling aspirate to whomever was ailing. But then you've got
a lot of companies that were producing copycats. They essentially,
you know, we're creating their own and we're making their own. Yeah,
(20:48):
they're just making their own. Uh. Aspirin essentially or asked
generic aspirin um and Bayer ended up going into litigious
actions suing lots of different companies and individuals. The courts
in the United States, however, decide the Bayar couldn't demand
stores to remove generic versions of aspirant to prevent them
from being made or prevent them from being made. Rather,
(21:09):
so then you get to the Second World War, and
that also reinforced this idea that the United States really
needed to invest in research and development of its own
as far as medicines are concerned. It could no longer
depend upon outside sources to develop this medication. So they
started to really, uh we see see a kind of
(21:29):
a a boom in the pharmacological industry here in the
US post World War two. Yeah, yeah, we all realized
it was it's it's a national resource. It's it's important
to be able to be able to fix our our populace.
It's it's it was. It was essentially a type of
national security, right, just like just like we talked about
(21:50):
fuel in terms of national security today, medicine certainly fell
into that same category. Um. And you often will hear
arguments similar to the US today about companies that develop
a drug and of course they will protect that drug,
and for the duration of that protection they can charge
pretty much whatever they like, and there's not really any
(22:11):
alternative to it. And you talk about things like, well
that that seems really predatory. Well, during post World War
two era, we were attempting to avoid a global version
of that. We still have the corporate version of that.
So then you get into the idea of patents. Uh,
now this we brought this up earlier, Joe. You mentioned
(22:32):
patent medicine. Patent medicine ironically counterintuitive name, Yeah, ironically it
doesn't have a patent. A patent medicine is usually what
we call. You know, you had a snake oil sales
and running around with a cart full of bottles of
something called like you know, Uncle Uncle Jimmy's Cure Everything juice,
And I always think of a rheumatism, diarrhea and cancer. Yeah,
(22:57):
fix it all and who turns out? What's in it
is usually like alcohol and some turpentine or something. It
always it always makes me think of a Doc Terminus
from the movie Pete's Dragon, Uh, played by Jim Dale,
an amazing Disney villain anyway, so he's not in the
new one. I digress. I was on a Disney cruise,
(23:20):
so my mind is also still with Disney. Um. So, yeah,
patent medicine was not patented and The reason it wasn't
patented is that when you file for a patent, you
have to explain what your invention is and how it
works in general, and the idea being that if you've
come up with an idea, and you that idea has
the potential to benefit mankind as a whole, then by
(23:44):
filing for the patent one you've protected your idea. You
you are supposed to be granted exclusive rights to that
idea for a certain length of time, however long the
patent is good for. Once that time expires, anyone can
use the patent you have filed as the basis for
their own work, and they can make their own version
(24:05):
of the thing you have invented. Yeah. So, so what
you get into with with stuff like patent medicines is
the idea that that you don't want anyone else to
ever make the stuff that you just made, or at
least or you don't want to have to prove that
it works and that too. Yeah, yeah, one of the two, certainly,
you know. For for example, I believe that the w
(24:26):
D forty is still not patented because the makers of
it just don't want anyone It's like a trade. Yeah.
So people who purveyors of patent medicine would claim that
their medicines are trade secrets to they don't want the
secret out because they are the ones who produce this
miracle cure and uh and and they're doing so responsibly
(24:48):
and you should buy from them. Meanwhile, patented medicines have
actually gone through this process of being filed with a
patent office and being issued a patent. So patent medicine
versus patented medicine, they're opposite of each other, which is
hard to get your mind around when you first start
reading about these sort of things. Also tells us that
(25:11):
patent medicine it's a historical term. Yeah, yeah, yeah, although
actually I wonder if some of the alternative medicines out there,
um kind of fall into that same category. Yeah, I
would imagine so well, and a lot of those alternative medicines.
You know, people say, well, this is not a drug.
It has a chemical component in it that has a
(25:33):
pharmacological effect. By definition, it's a drug. It's just an
unregulated drug that you cannot guarantee that you will have
the same amount of active ingredient from one dose to
the next. I'd say most not legally speaking, but Yeah,
most alternative medicines today probably don't have turpentine in them,
so they're less likely to make you violently sick. I do,
(25:54):
Like you said, most and probably, but they might not
be any more effect at any rate. You know this,
This whole discussion of patent versus patented illustrates that language
is dumb. Uh. Also, we can we should mention that
drugs are not just necessarily protected by patents. Patents do
(26:15):
expire after a given term like seven to twelve years,
depending upon the place and the type of patent you're
talking about. Um, and sometimes some patents again, depending on
where you are, could last longer than that. Uh. Drugs
can also be protected by trademarks. Now, trademarks are not
protecting the composition of the drug. It's really protecting the brand,
(26:35):
the name, right, the name and perhaps the way that
the bottle looks, stuff like that, Yes, exactly, or even
the design of the pill. Yeah exactly. So So if
if what was our what was our fancy drug scalp SCALP,
now that's the that's the patented version, well that would
be they would also be the trademarked version. Yeah. Yeah, yeah,
(26:55):
you can't call just any old q hi hyd Uh
scalp extra right, you have to come up with another
scalp pun and you couldn't. You couldn't market it in
a bottle that looked similar to a scalpex or bottle
because most likely that would also be trademarks are too
similar to similar, and trademark is one of those things
that you have to defend in order to keep it.
(27:18):
If you trademark something and you don't defend that trademark,
then uh you can you won't have a whole lot
of ground to stand on if you ultimately decide, hey,
I've had enough of this, I'm going to go out
there and go after these guys. Yeah, I've heard that
that's a common explanation for like, oh, why is some
company being a jerk going after some small fish? You
did some you know, little tiny trademark infringement. Uh, And
(27:41):
I think it's sort of about legal precedent. They're afraid
if some rival company seems that they haven't pursued trademark
infringement rights against the small fish, then they have the
precedent to take advantage of it at a large scale exactly.
So Uh. Again, once that exclusivity of the the patent
expires and other companies are allowed to get into the
(28:04):
game and use that same idea to make their own product.
That's where you see generic drugs come in. In the
chemical side of things, like the small molecule type of drugs. Uh,
that's when generics can hit the market. It's also when
biosimilars can hit the market. But the big difference here
is that when you're talking about a biosimilar drug. Uh,
(28:25):
the people who make or the companies that make biologic
therapies don't have to reveal everything that goes into making
that therapy. And you mentioned this earlier, Yeah, because because
when you write when when when you patent to this
kind of thing, you're not necessarily patenting the process. You're
patenting the resulting product. Um, you can separately patent to
(28:49):
the process. Maybe sometimes depending on what machinery you've created
or stuff like that. But uh, but in general, since
you're working with with living tissue and living systems and
and stuff that is unpatentable like DNA, it falls into
that trade secret category. Right. So then that means if
you want to create a biosimilar, then what you have
(29:11):
to do is kind of work backward. You might know
in general what goes into the biologic therapy, but in
order to get to that destination, you may have to
plot your own course, and thus you have to go
through that big clinical testing because the the approach you
take might be dramatically different from the approach the the
(29:31):
producer of the reference drug took. So let's talk a
little bit about the history of biosimilars. This was interesting
to me too, because it went back further than I
had imagined when you start talking about biological therapies. So
in the US, the government got involved with biologically derived
products way back in nineteen o two with the Biologics
Control Act nineteen o two. UH. And it actually was
(29:56):
this This shouldn't really be much of a surprise. It
was that response to a tragedy that had happened in
nineteen o one. There was a diph theory any toxin
serum that was derived from the blood of horses, and unfortunately,
one batch of that antitoxin serum caused the deaths of
thirteen children. When there was an investigation to find out
(30:17):
what caused this, UH, it went back to a St.
Louis manufacturing company that had used the blood of a
horse that had been infected with tetanus. So the Act
was created specifically to put protections in place to prevent
that sort of thing from happening again in the future. Now,
with a lot of these biologic therapies, a lot of
them are are relatively young. I mean, they don't all
(30:39):
date back to nineteen o two, right, so some of
them are just getting to the age where those patents
that were filed back when they were first developed are
expiring soon. That is another reason why this discussion of
biosimilars has kind of popped up in the media, because
we're now getting to a point where that protects and expires,
(31:00):
and other companies can actually legally create their biosimilars to
the biologic therapy, and recently it's happened with a couple
of drugs I believe for for rheumatism, for for rheumatoid I.
Threat is right, and this is still so new that
we don't have a really well thought out policy that
(31:21):
that is specifically intended to regulate this sort of stuff.
In the United States, biosimilars currently fall under the regulation
of the FDA's Public Health Service Act, but there are
motions to create a formalized approach to the testing and
approval to biosimilars. So right now, the way if the
FDA treats this, it makes sense if you were listening
(31:43):
earlier to the podcast, they treat it like every biosimilar
is actually an entirely new biologic therapy, right so it's
just the same as if you had come up with
a brand new process to treat a specific illness or
set of symptoms. And so a lot of people are thinking, well,
there's got to be a better way of doing this,
(32:05):
and that in turn will one encourage more companies to
develop biosimilars and to help bring that cost of the
final therapies down, because if you're able to streamline this approach, uh,
the investment on the end of the companies won't be
as great SUH. And I did want to also put
in that not all biologic therapies fall under the regulations
(32:30):
for for for this biosimilar drug kind of thing, like
a like if if you if if you've ever taken
insulin or birth control pills, then you know that those
are regulated the same way that the chemical drugs are
here here in the United States at any rate, and
so so generics of those can be made and called
generics even though they're technically a biologic therapy. Uh and
(32:51):
it's for a number of honestly exhausting legal reasons that
those have been categorized that way. But yeah, So glancing
again in the future, it looks like biosimilars are going
to play an increasingly important role in medicine. It may, however,
not lead to some sort of glorious renaissance of cheap therapies. Right,
(33:16):
we may see less expensive therapies. In fact, if we
don't see less expensive therapies, they're gonna be some companies
that are out of some serious money. Because the only
reason to get into the game is if you can
produce a a therapy that is effective for the treatment
of a particular condition or illness or whatever at a
lower selling cost than the the leading brand of that therapy.
(33:43):
Otherwise you're not you're not gonna sell anything. You're not
gonna you don't have a you don't have something to
entice people to buy your approach versus the name brand approach.
So they will be cheaper. The question is will they
be significantly cheaper, And they may not be. There are
some people who are skeptical that it will be a
(34:03):
significant drop in price. So then we also have other
complications such as how are they going to be affected
through things like insurance, Like how how is insurance going
to um cover a biosimilar versus the reference biologic therapy?
And we don't have the answers to this yet. These
(34:24):
are still questions that have to be solved. And keep
in mind that we're talking about a realm of science
that is still relatively young and is outpacing legal and
insurance realms. So it's gonna be messy for a while
and it may not shake out for several years until
we've reached a point where we have a better understanding
(34:46):
on from all perspectives. Yeah. Yeah, if you're asking about
the direct future of biosimilar as, I would say that
it's something of a regulation headache at the current moment.
I mean, you know, partially for for the reasons of
protecting um these companies interests, but also for the reasons
of protecting doctors and patients as they come to understand
(35:07):
how the products work and comprehend the potential risks and
using them versus a previous therapy that they have used. Right, So, ultimately,
I think what we're going to see is that these
therapies and similar therapies, these biologic therapies, whether it's the
reference one or the the various bios similars out there,
they're going to become more accessible and at least in theory,
(35:31):
they will become less expensive. Both of those are good things. Uh,
It's just one of those deals where we really felt
that a lot of that coverage out there was treating
this so so much on a surface level that it's
hard to understand why it's complicated until you start really
diving into it, you realize, Oh, it's complicated because one
(35:52):
you're talking about biology, which is not necessarily simple. I mean, uh,
you know, every time you work with a cell, you're
not guaranteed have specifically the identical experience like you would
with using the exact same chemicals in a pristine laboratory setting. Yeah. Sure.
And although the ingredients in in many biosimilar drugs, the proteins,
(36:15):
the sugars, the DNA bits, any of that stuff is
hypothetically a chemical and hypothetically can be reproduced consistently, you
don't again, because you throw in that that you're doing
stuff with living stuff factor. Yeah, living stuff can have
slight differentiation from from instance to instant. Yes, so that
(36:39):
ends up being a bit of a complication. But then
on top of that, you've got the complication of that
where people and we have to figure out how to
handle this new, relatively new discipline and uh. And so
that's why it's so complicated, partially because we made it
that way. But this was really interesting to look into.
I really learned a lot as I started to research
(37:01):
this stuff that you know, I thought I knew, and
then as I was reading, I'm like, wow, I had
a complete Uh, I had the wrong perspective on this.
You know, this topic makes me think that in the future,
we should maybe do an episode entirely devoted to the
future of medical research incentives, because the whole the thinking
behind the patent system, as you said earlier, you know,
(37:23):
part of it is about in the long term, sharing information,
but it's also about providing incentive for research. Right is
saying that it's sort of giving you a guarantee that
if you forge a path that is a productive path,
you will reap rewards from it, and other people can't
scoop your rewards away. Um, And so I wonder, I
(37:45):
wonder if they're interesting trains of thought about what types
of incentives for research will continue into the future. I mean,
will you always have to have the same kind of
promise from the market to make people invest the time
and money into life saving research. Well, and we could
also have an interesting discussion about Salk and the polio vaccine,
(38:10):
because there's the the infamous exchange where he developed the
polio vaccine and he was asked who holds the patent
on it? And he says, well, I I suppose the
people hold the patent on it. I mean, would you
patent the sun? And so there are people who champion
him as saying that this was a person who developed
a uh an approach to stave off a devastating disease
(38:35):
for the good of all humans, right, like an altruistic act,
And the truth of the matter gets a little more
muddy and complicated. But that would be a great side
discussion for that particular episode, I would say, so keep
an ear out for that in the future. Meanwhile, make
sure that you go and check out the videos we've
(38:56):
been doing for Forward Thinking this season. I think that
there's some of the strong ones we've produced so far.
And uh if you have any suggestions for future episodes,
or you have a question about something we've talked about
in the past, send it our way. The email addresses
f W Thinking at how Stuff Works dot com, or
you can drop us the line on Twitter where FW
(39:16):
thinking there, or search FW Thinking and Facebook. Our profile
will pop up. You can leave us a message and
we will talk to you again really soon. For more
on this topic in the future of technology, visit forward
thinking dot com. Brought to you by Toyota Let's Go
(39:45):
Places
Brought to you by Toyota. Let's go places. Welcome to
Forward Thinking. Hey there, and welcome the Forward Thinking, the
podcast that looks at the future and says, no pills
gonna cure my ill. I got a bad case of
(00:20):
loving you. I'm Jonathan Strickland, and I'm Joe McCormick. And Jonathan,
you're back. I am back, but you might notice this
is a really appropriate thing for us to cover today
because my voice is dying. I've had I've been fighting
off a little bit of a cold for it ever
since I got back. Did you get cruise crud? Either
(00:41):
cruise cut crud or the European boogie flu? I don't know.
I mean it was. I had a great time. I
sailed around the British aisles. We told the listeners many
untrue stories or might not be dead. Yeah, I got
a lot of concerned tweets that was dead. I don't
think we said Dad was heard. It was almost definitely.
(01:02):
Didn't tell anyone you were down. That's good. So we
may have mentioned Quidditch made dismissive comments about France. I was,
in fact at a castle where they did shoot some
of the Quidditch scenes from Harry Potter on Castle Historic
Comma The Percy's I was there for Hotspur, my wife
was there for Harry Potter. Anyway, none of that has
(01:23):
anything to do with what our topic is today, but
the fact that I was talking about feeling a bit
under the weather does kind of because we're talking about biosimilars,
a type of drug, and you may have heard this term,
and some of you may even be very familiar with it,
but I to to just be honest, I had heard
the term, but didn't really understand it until we started
(01:46):
doing research for this episode. I think I think I
knew nothing about it. Yeah, I think that I completely
misunderstood it. We were talking right before we started up
about how it was sort of a difficult topic to
to wrap our heads around, partially because some of the
parding about it is a little bit confused itself. Yeah,
it's not misleading, at least not clear right or just
(02:08):
not going into depth. I think I didn't really understand
before the difference between biosimilar drugs and generic drugs, right
and and and biosimilar drugs been in the in the
press a little bit lately because of some stuff floating
around the f d A hopefully not literally that that
that has to do with with the way that these
(02:29):
drugs are are going to be regulated in maybe the
near future, uh, maybe a little while from now, but
but yeah, So, so there is a distinct difference between
biosimilar drugs and generic drugs. And let's let's let's figure
that out. Let's lay down these these ground definitions, right,
So first, let's just start with just the basic idea
of what is a drug. Let's manufacture some drugs. Wow
(02:53):
this episode with Downhill in a hurry. All right, So
the drug is, at its most basic level, some sort
of molecule that has a pharmacle logical effect on something organic.
And we are going to talk about drugs for humans
because that's what we are. I mean, I don't want
to speak for all of us. I'm not I am
definitely not almost sure. I'm definitely not a reptilian. I'm
(03:14):
not going to not say that I'm a reptilian. Okay,
I'm mostly interested in drugs for wizards. Can we talk
about those. We'll get back to quidditch later. So typically
when we talk about drugs, we're talking about ones that
were designed through chemistry in a lab. That's the majority
of the drugs we use today are of that category.
(03:35):
Not all of them are. Some of them are biologic
as opposed to, uh the the chemical approach, but we'll
get into that. So when a pharmaceutical company develops a drug,
it's really trying to build a molecule meant to have
a particular effect on the person taking the drug, whether
it's to fight a particular illness or alleviate symptoms or
something along those lines. It's it's it's meant to make
(03:58):
some kind of chemical change in your body in order
to do a stuff right. Right, And typically the active
ingredient is the drug itself, but an active ingredient is
not the only ingredient in most drugs. You tend to
have a lot of other stuff that is there. Maybe
it's to act as almost like a catalyst. Sometimes it's
just a filler to a carrier system to get the
stuff into your stuff. Sure, yeah, so you we in
(04:21):
the getting over into the generic drug area. UM, you
would first call one of those drugs like the main
one that has already been developed by a company. It's
been uh filed with intellectual property, so it has its
own proper name that does not necessarily relate to any
of the chemicals inside that drug. It's usually a pun
(04:41):
of some kind. Yeah, yeah, you get some or you'll
just get like it will sound vaguely scientific, but then
you realize that that's just a brand name that someone
came up when they said this is testing. Well, yeah,
maybe it would help to have an example to continue
through this. Let's do aspirant. I was gonna make one up. Okay,
go go ahead, make one up. Well, let's say you
invent a small molecule drug that causes rapid balding for
(05:04):
people who don't like to have haircuts. You know, they
just don't want to deal with it. Advanced rapid balding.
And I feel like I'm being attacked in this episode
talking about I feel like I'm I've been advanced rapid
balding for years. So this drug, the brand name version
of it that is patented by the original drug innovator,
(05:25):
is called Scalp Extra. Scalp Extra, that's that's the that's
the brand name, brand name. Yeah, so there's an active
ingredient in scalprexa. Uh what Scalp extra. Sorry, Um, well
I don't need it, obviously, I've already it's it's worked
on me. So Scalp Extra is the brand name. What
(05:47):
is the active ingredient? Makes something else up? Uh, it's sugar.
I don't know what it is. It's a chemical, I
don't I know, But you can just make up a
name for a chemical. Two for the purposes of this,
It's called cubal hydride. Alright. Cubal hydride is the active
ingredient in scalp extra. Alright, cubal hydride. So, uh so
(06:10):
in the in the terms of generic drugs, you would
have scalpexor, which is your reference drug, all right, and
then cubal high what was it? Cub hyd cuble hydride
is your is your actual active ingredient that becomes the
generic term for that drug, all right. So generics are
(06:31):
are drugs that have the same active ingredient as a
brand name, and they are meant to have the same
pharmacological effect as the reference drug that brand name drug
Scalp Extra in this in this example that we have created.
So if they're the same thing, in what sense is
the generic different? Well, it has basically just to do
with intellectual property law, right pretty much. Yeah. Yeah, So
(06:53):
after the patent lifetime of the original patent on that
drug expires for the drug innovator, then another company can
come along and say, well, I want to make this
same drug, but basically the only thing they can't do
is call it by the same name. So and and
frequently the some of the non active ingredients will be different, right,
(07:14):
which also partially explains why if you've ever noticed that
sometimes generic drugs don't work exactly the way that that
that a brand name drug does. It could be a
placebo effect, or it could be a genuine chemical difference
in the way that the drug is entering your system.
Right there. There can be cosmetic differences to it can
be shaped, your color different, well, it might be a
(07:34):
pill versus like the gelatine capsule type stuff. It all depends, right. So,
the in the United States, the Food and Drug Administration
has very specific rules for generic drugs and says that
generic drug must be identical or within a range of
bioequivalence to the reference drug. So it has to be
that way. Now, biosimilar drugs are different from this. They
(07:56):
are not meant to be chemically identical to a reference drug.
You still do have a reference drug, so they're intended
to produce medicinal effects that they are. One, they're not
created through chemical synthesis, and the molecular structure is much
larger and more complex than traditional brand name drugs or generics.
(08:16):
So you first start off with a biologic therapy of
some sorts. So this is this is similar in a
way to the reference drug we talked about a second ago,
the brand name drug, but in this case it's biologically
derived UM and biosimilar is meant to replicate the effects
of the reference drug, the biologic therapy, but it doesn't
(08:39):
have to at all molecular lee resemble that reference drug,
right because Okay, So, biological therapies are products that are
made from biological sources, their extractions from cells or tissues
or or stuff that is made inside cells and tissues. Uh.
They can also be called biopharmaceuticals or biologics, and they
(08:59):
include things like like like hormone therapies, vaccines, blood components,
gene therapies, anti venom or antitoxin, insulin, stuff like that, Right,
And so keep in mind we're we're talking about both
generics and biosimilars are supposed to achieve the same results
as their references. But in the case of generic drugs.
(09:20):
When you break it down chemically, it is for all
intents and purposes, identical to the reference. It does the
same thing because it is the same right, right, It's
it's a chemical structure, um and and biologic therapies are
are more complicated because of a the way they're produced
and be the stuff that they're made of. Right. So
if you want to have like an analogy that's not
(09:40):
drug related, you could say that if you look at
a catapult and a giant sling shot, they both can
propel an object a very great distance. They do it
in slightly different ways, but the end result is the
same and they don't physically resemble one another, right, So
you could if you could design it in such a
(10:01):
way where some of the same elements some of the
same elements, which is true with biosimilars as well. So
that's why I wanted to say, like again, you've got
to think of biosimilars as being an attempt to create
the same effect as some other reference, but it isn't
identical to the reference. Not only that, but if you
have two different companies trying to make biosimilar drugs, so
(10:24):
you've got your reference biological therapy, right, that's created by somebody.
You have two other companies that want to make a
biosimilar therapy using that first one as its reference. The
two biosimilar therapies won't resemble one another either. They will
resemble the they won't physically. Yeah, I mean, I mean
because because you have to reverse engineer. Because we'll look
(10:48):
into this in a minute. But but but the way that
these things are patented, Uh, people don't or companies rather
don't have to write down everything about their process. They
just they just patent the end result and so um so,
so when when another company comes along and tries to
reverse engineer that process, then what they come up with
might be wildly different. Yes, And so, as we've already
(11:12):
alluded to, making these things is complicated. I mean, you're
you're talking about like almost like growing a drug as
opposed to synthesizing one through chemistry. And because of this,
the whole process requires a lot of precision and expertise.
It is not an easy thing to do. It's not
easy to produce it on a mass scale either. So
(11:34):
for uh, that reason, a lot of biologic therapies tend
to be incredibly expensive because it's not it's not easy
to do, and it's not easy to do on a
big scale. So in order to balance that out, companies
end up charging more for their various biologic therapies. It's
not true in every single case, but in a lot
of cases it is, so there was there's hope that
(11:57):
biosimilars can help bring that cost down own. But we'll
get into how that gets a little complicated and just
a little further um. Now, the other issue we need
to talk about is the idea of testing drugs. We've
talked about drug testing and clinical trials in previous episodes.
This is a pretty exhaustive process for good reason. You
(12:18):
want to make certain that the drug that you are
developing is efficacious and it is not toxic. Without this process,
we would be back in the era of patent medicine, right, yes,
And we'll talk about patent medicine pretty soon too. Patent
medicine and patented medicines yet more confusing terminology. But that
is an excellent, excellent point. I mean, we would if
(12:40):
you go, if you think about it, without that clinical testing,
you're getting down to, uh, the idea that that a
company could sell a drug claiming that it has an
effect without having to prove it or even make certain
that it isn't it self harmful to people, and we
don't want that. That's why we have organizations like in
(13:01):
the US, the Food and Drug Administration to make sure
that companies are following very specific guidelines to not cause harm.
So with generic drugs, the testing is a little more
simple because you've already got a reference drug that is
chemically identical to the generic drug, at least for the
(13:23):
active ingredient, So you already know what it does to people, right, Yeah,
it's already it's already passed through clinical trials before it
could ever go onto the market. Now that doesn't that
doesn't mean generic drugs get a free pass and just
immediately go straight to store shelves, but it does mean
that a lot of that work has already been done,
and so the clinical trials are usually smaller and less exhaustive.
(13:45):
I would say that's probably also a reason why generic
drugs are cheaper. Well, yeah, because as much to get
to the stores, right, yeah, I think they can be
more profitable little at a lower cost. Right, And and
they're also cheaper because at that point it's a longer monopoly, right,
you can't. Now, they can undercut, right, they can undercut
(14:06):
the the the main proprietor of said drug. Well, biosimilars
are totally different, right, because we've just said a biosimilar
drug can be completely structured in a different way than
it's reference drug. Um it's supposed to do the same
thing pharmacologically, but structurally it could be very different. Because
it could be very different, then there's the question of well,
(14:27):
will this have different symptoms, will be have a different
toxicity level than say, the reference drug does. It has
to undergo much more extensive clinical trials than generics tend to.
So that is another reason why the cost difference between
a biosimilar drug and the reference drug may not be
as great as you would see in generic drugs, because
(14:51):
you still have to undergo this incredibly exhaustive testing for
good reason. I'm not I'm not suggesting that that's a
bad idea. Sure, yeah, yeah, but but the but the
market is still in play. You'll still have the effect
of um of companies attempting to undercut each other's prices. Right,
The question is just how far lower can they go?
Considering the fact that the UM the investment in biosimilars
(15:13):
is generally speaking higher than it is to go into
the business of designing generic drugs, or not designing but
producing generic drugs. So let's let's talk about this idea
of copyrights and patents because it does play directly into
generics and biosimilars. It's not all science and technology, it's
also economics and intellectual property. Um. So when you start
(15:35):
looking at large scale drug manufacturing, you have to go
all the way back to the Revolutionary War here in
the United States. That's when uh Andrew Craiggie begin established
a manufacturing facility in Pennsylvania and he became the first
Apothecary General of the United States. General. We don't have
one of those anymore, we know he's entitled though. Yeah
(15:59):
we got got rid of got rid of that shortly
after the Alchemist General. Um. But so by seventeen inventors
were starting to file patents in the United States for
medical devices and medicines. By the mid eighteen hundreds, companies
began to form around new manufacturing practices, which at the
time that was actually more important than the medicines themselves.
(16:21):
The way you manufactured them became much more important than
whatever it was you were making uh. And the reason
for that is that in the United States we were
really dependent upon other parts of the world to actually
research and develop medicines. Then what would happen is those entities,
mostly in Europe, would essentially license the medicines into the
(16:45):
United States where we could produce them here, but it
was because somewhere else that's where that's where they were
being developed. So it was like an interesting thing to
look at that that we weren't really developing drugs in
the US at that time, we were simply producing them
based upon the work people in Europe were doing. So
that actually became a bit of a problem because well
(17:08):
by the end of the nineteenth century, German manufacturers were
holding most of the patents around major medicines in the
United States UM and in fact, there were subsidiary companies
in the U S subsidiaries of those German companies that
were producing the drugs here in the US, and they
didn't have the full recipe. Like it's like you would
get a jar with you know ingredient X, and then
(17:30):
you would you would go ahead and do the mixture
as right, but you didn't know what was in ingredient X. Um,
so it was kind of interesting that it was being
kept as a sort of a trade secret, so even
though it was being produced in the US, people in
the U s didn't know what was going into it.
But okay, so we're we're coming out of the eighteen
hundreds going into the nineteen hundreds, and lots of these
(17:53):
companies were from Germany. Yeah. Yeah, so you're you're you're
getting your you're thinking about like what have ends around oh,
nineteen fourteen too, that you know, are somewhere around that
range where you know, some conflict is happening in Europe.
They they're entering into a you know, the war to
end all wars. Yeah, except you know, of course it
didn't end all wars so much so that no one
(18:16):
at the time called it World War One because they
were all very optimistic. Um though, at any rate, world
War one happens, and because it happens, it ends up
creating a problem where the US is not able to
access those drugs, those medicines that were coming from Germany anymore.
(18:38):
The United States was trying to find ways to make
certain that it wasn't providing financial support to Germany during
World War One. Sure, I'm sure that also some trade
routes were a little bit disrupted by by the little
bit seating. Yeah, so there was actually a lot past
that that basically let Americans get around this, this entire thing. Yeah. Yeah,
(19:00):
you get to a point where you're like, well, how
do we how do we deliver upon medicines? How do
we do this in this time of tribulation? What what
are our options? The United States government in nineteen seventeen
passes the Trading with the Enemy Act and then actually
allowed companies to produce products that were otherwise protected by
patents if those patents were held by individuals or companies
(19:20):
and enemy states. Its invenient. So right, like, your intellectual
property doesn't count if you are at war with the
United States and such a fascinating precedent. I love that. Yeah,
it's It's also the way I live my life. When
I get into a spat with somebody, I'm just like, well,
their ideas are no longer relevance, and I can I
can take whatever they had. Well, now, so does this
(19:44):
also mean that if somebody like physically assaults you, you
can plagiarize their novel? I mean, that's how princip If
that's accurate then I'm gonna I'm gonna go to go
out to the writer events and like just start picking
fights with people. So like, oh man, what are you
gonna do? Punch me, I'm gonna steal your short story.
(20:06):
I think you're gonna need to be a little more
specific with your wording because technically you can do that.
You just can't get away. Uh. Yeah, you can't get
away with it. But you you you could physically do
that thing. Um. So we get through World War One, uh,
and then we started getting into a new thought process
in the United States. And this is what allows generic
(20:28):
drugs to really become a thing. Back in the nineteen twenties.
It's a little company called Bayer, going back to aspirin. Uh.
They were writing high on the headaches of the world,
selling aspirate to whomever was ailing. But then you've got
a lot of companies that were producing copycats. They essentially,
you know, we're creating their own and we're making their own. Yeah,
(20:48):
they're just making their own. Uh. Aspirin essentially or asked
generic aspirin um and Bayer ended up going into litigious
actions suing lots of different companies and individuals. The courts
in the United States, however, decide the Bayar couldn't demand
stores to remove generic versions of aspirant to prevent them
from being made or prevent them from being made. Rather,
(21:09):
so then you get to the Second World War, and
that also reinforced this idea that the United States really
needed to invest in research and development of its own
as far as medicines are concerned. It could no longer
depend upon outside sources to develop this medication. So they
started to really, uh we see see a kind of
(21:29):
a a boom in the pharmacological industry here in the
US post World War two. Yeah, yeah, we all realized
it was it's it's a national resource. It's it's important
to be able to be able to fix our our populace.
It's it's it was. It was essentially a type of
national security, right, just like just like we talked about
(21:50):
fuel in terms of national security today, medicine certainly fell
into that same category. Um. And you often will hear
arguments similar to the US today about companies that develop
a drug and of course they will protect that drug,
and for the duration of that protection they can charge
pretty much whatever they like, and there's not really any
(22:11):
alternative to it. And you talk about things like, well
that that seems really predatory. Well, during post World War
two era, we were attempting to avoid a global version
of that. We still have the corporate version of that.
So then you get into the idea of patents. Uh,
now this we brought this up earlier, Joe. You mentioned
(22:32):
patent medicine. Patent medicine ironically counterintuitive name, Yeah, ironically it
doesn't have a patent. A patent medicine is usually what
we call. You know, you had a snake oil sales
and running around with a cart full of bottles of
something called like you know, Uncle Uncle Jimmy's Cure Everything juice,
And I always think of a rheumatism, diarrhea and cancer. Yeah,
(22:57):
fix it all and who turns out? What's in it
is usually like alcohol and some turpentine or something. It
always it always makes me think of a Doc Terminus
from the movie Pete's Dragon, Uh, played by Jim Dale,
an amazing Disney villain anyway, so he's not in the
new one. I digress. I was on a Disney cruise,
(23:20):
so my mind is also still with Disney. Um. So, yeah,
patent medicine was not patented and The reason it wasn't
patented is that when you file for a patent, you
have to explain what your invention is and how it
works in general, and the idea being that if you've
come up with an idea, and you that idea has
the potential to benefit mankind as a whole, then by
(23:44):
filing for the patent one you've protected your idea. You
you are supposed to be granted exclusive rights to that
idea for a certain length of time, however long the
patent is good for. Once that time expires, anyone can
use the patent you have filed as the basis for
their own work, and they can make their own version
(24:05):
of the thing you have invented. Yeah. So, so what
you get into with with stuff like patent medicines is
the idea that that you don't want anyone else to
ever make the stuff that you just made, or at
least or you don't want to have to prove that
it works and that too. Yeah, yeah, one of the two, certainly,
you know. For for example, I believe that the w
(24:26):
D forty is still not patented because the makers of
it just don't want anyone It's like a trade. Yeah.
So people who purveyors of patent medicine would claim that
their medicines are trade secrets to they don't want the
secret out because they are the ones who produce this
miracle cure and uh and and they're doing so responsibly
(24:48):
and you should buy from them. Meanwhile, patented medicines have
actually gone through this process of being filed with a
patent office and being issued a patent. So patent medicine
versus patented medicine, they're opposite of each other, which is
hard to get your mind around when you first start
reading about these sort of things. Also tells us that
(25:11):
patent medicine it's a historical term. Yeah, yeah, yeah, although
actually I wonder if some of the alternative medicines out there,
um kind of fall into that same category. Yeah, I
would imagine so well, and a lot of those alternative medicines.
You know, people say, well, this is not a drug.
It has a chemical component in it that has a
(25:33):
pharmacological effect. By definition, it's a drug. It's just an
unregulated drug that you cannot guarantee that you will have
the same amount of active ingredient from one dose to
the next. I'd say most not legally speaking, but Yeah,
most alternative medicines today probably don't have turpentine in them,
so they're less likely to make you violently sick. I do,
(25:54):
Like you said, most and probably, but they might not
be any more effect at any rate. You know this,
This whole discussion of patent versus patented illustrates that language
is dumb. Uh. Also, we can we should mention that
drugs are not just necessarily protected by patents. Patents do
(26:15):
expire after a given term like seven to twelve years,
depending upon the place and the type of patent you're
talking about. Um, and sometimes some patents again, depending on
where you are, could last longer than that. Uh. Drugs
can also be protected by trademarks. Now, trademarks are not
protecting the composition of the drug. It's really protecting the brand,
(26:35):
the name, right, the name and perhaps the way that
the bottle looks, stuff like that, Yes, exactly, or even
the design of the pill. Yeah exactly. So So if
if what was our what was our fancy drug scalp SCALP,
now that's the that's the patented version, well that would
be they would also be the trademarked version. Yeah. Yeah, yeah,
(26:55):
you can't call just any old q hi hyd Uh
scalp extra right, you have to come up with another
scalp pun and you couldn't. You couldn't market it in
a bottle that looked similar to a scalpex or bottle
because most likely that would also be trademarks are too
similar to similar, and trademark is one of those things
that you have to defend in order to keep it.
(27:18):
If you trademark something and you don't defend that trademark,
then uh you can you won't have a whole lot
of ground to stand on if you ultimately decide, hey,
I've had enough of this, I'm going to go out
there and go after these guys. Yeah, I've heard that
that's a common explanation for like, oh, why is some
company being a jerk going after some small fish? You
did some you know, little tiny trademark infringement. Uh, And
(27:41):
I think it's sort of about legal precedent. They're afraid
if some rival company seems that they haven't pursued trademark
infringement rights against the small fish, then they have the
precedent to take advantage of it at a large scale exactly.
So Uh. Again, once that exclusivity of the the patent
expires and other companies are allowed to get into the
(28:04):
game and use that same idea to make their own product.
That's where you see generic drugs come in. In the
chemical side of things, like the small molecule type of drugs. Uh,
that's when generics can hit the market. It's also when
biosimilars can hit the market. But the big difference here
is that when you're talking about a biosimilar drug. Uh,
(28:25):
the people who make or the companies that make biologic
therapies don't have to reveal everything that goes into making
that therapy. And you mentioned this earlier, Yeah, because because
when you write when when when you patent to this
kind of thing, you're not necessarily patenting the process. You're
patenting the resulting product. Um, you can separately patent to
(28:49):
the process. Maybe sometimes depending on what machinery you've created
or stuff like that. But uh, but in general, since
you're working with with living tissue and living systems and
and stuff that is unpatentable like DNA, it falls into
that trade secret category. Right. So then that means if
you want to create a biosimilar, then what you have
(29:11):
to do is kind of work backward. You might know
in general what goes into the biologic therapy, but in
order to get to that destination, you may have to
plot your own course, and thus you have to go
through that big clinical testing because the the approach you
take might be dramatically different from the approach the the
(29:31):
producer of the reference drug took. So let's talk a
little bit about the history of biosimilars. This was interesting
to me too, because it went back further than I
had imagined when you start talking about biological therapies. So
in the US, the government got involved with biologically derived
products way back in nineteen o two with the Biologics
Control Act nineteen o two. UH. And it actually was
(29:56):
this This shouldn't really be much of a surprise. It
was that response to a tragedy that had happened in
nineteen o one. There was a diph theory any toxin
serum that was derived from the blood of horses, and unfortunately,
one batch of that antitoxin serum caused the deaths of
thirteen children. When there was an investigation to find out
(30:17):
what caused this, UH, it went back to a St.
Louis manufacturing company that had used the blood of a
horse that had been infected with tetanus. So the Act
was created specifically to put protections in place to prevent
that sort of thing from happening again in the future. Now,
with a lot of these biologic therapies, a lot of
them are are relatively young. I mean, they don't all
(30:39):
date back to nineteen o two, right, so some of
them are just getting to the age where those patents
that were filed back when they were first developed are
expiring soon. That is another reason why this discussion of
biosimilars has kind of popped up in the media, because
we're now getting to a point where that protects and expires,
(31:00):
and other companies can actually legally create their biosimilars to
the biologic therapy, and recently it's happened with a couple
of drugs I believe for for rheumatism, for for rheumatoid I.
Threat is right, and this is still so new that
we don't have a really well thought out policy that
(31:21):
that is specifically intended to regulate this sort of stuff.
In the United States, biosimilars currently fall under the regulation
of the FDA's Public Health Service Act, but there are
motions to create a formalized approach to the testing and
approval to biosimilars. So right now, the way if the
FDA treats this, it makes sense if you were listening
(31:43):
earlier to the podcast, they treat it like every biosimilar
is actually an entirely new biologic therapy, right so it's
just the same as if you had come up with
a brand new process to treat a specific illness or
set of symptoms. And so a lot of people are thinking, well,
there's got to be a better way of doing this,
(32:05):
and that in turn will one encourage more companies to
develop biosimilars and to help bring that cost of the
final therapies down, because if you're able to streamline this approach, uh,
the investment on the end of the companies won't be
as great SUH. And I did want to also put
in that not all biologic therapies fall under the regulations
(32:30):
for for for this biosimilar drug kind of thing, like
a like if if you if if you've ever taken
insulin or birth control pills, then you know that those
are regulated the same way that the chemical drugs are
here here in the United States at any rate, and
so so generics of those can be made and called
generics even though they're technically a biologic therapy. Uh and
(32:51):
it's for a number of honestly exhausting legal reasons that
those have been categorized that way. But yeah, So glancing
again in the future, it looks like biosimilars are going
to play an increasingly important role in medicine. It may, however,
not lead to some sort of glorious renaissance of cheap therapies. Right,
(33:16):
we may see less expensive therapies. In fact, if we
don't see less expensive therapies, they're gonna be some companies
that are out of some serious money. Because the only
reason to get into the game is if you can
produce a a therapy that is effective for the treatment
of a particular condition or illness or whatever at a
lower selling cost than the the leading brand of that therapy.
(33:43):
Otherwise you're not you're not gonna sell anything. You're not
gonna you don't have a you don't have something to
entice people to buy your approach versus the name brand approach.
So they will be cheaper. The question is will they
be significantly cheaper, And they may not be. There are
some people who are skeptical that it will be a
(34:03):
significant drop in price. So then we also have other
complications such as how are they going to be affected
through things like insurance, Like how how is insurance going
to um cover a biosimilar versus the reference biologic therapy?
And we don't have the answers to this yet. These
(34:24):
are still questions that have to be solved. And keep
in mind that we're talking about a realm of science
that is still relatively young and is outpacing legal and
insurance realms. So it's gonna be messy for a while
and it may not shake out for several years until
we've reached a point where we have a better understanding
(34:46):
on from all perspectives. Yeah. Yeah, if you're asking about
the direct future of biosimilar as, I would say that
it's something of a regulation headache at the current moment.
I mean, you know, partially for for the reasons of
protecting um these companies interests, but also for the reasons
of protecting doctors and patients as they come to understand
(35:07):
how the products work and comprehend the potential risks and
using them versus a previous therapy that they have used. Right, So, ultimately,
I think what we're going to see is that these
therapies and similar therapies, these biologic therapies, whether it's the
reference one or the the various bios similars out there,
they're going to become more accessible and at least in theory,
(35:31):
they will become less expensive. Both of those are good things. Uh,
It's just one of those deals where we really felt
that a lot of that coverage out there was treating
this so so much on a surface level that it's
hard to understand why it's complicated until you start really
diving into it, you realize, Oh, it's complicated because one
(35:52):
you're talking about biology, which is not necessarily simple. I mean, uh,
you know, every time you work with a cell, you're
not guaranteed have specifically the identical experience like you would
with using the exact same chemicals in a pristine laboratory setting. Yeah. Sure.
And although the ingredients in in many biosimilar drugs, the proteins,
(36:15):
the sugars, the DNA bits, any of that stuff is
hypothetically a chemical and hypothetically can be reproduced consistently, you
don't again, because you throw in that that you're doing
stuff with living stuff factor. Yeah, living stuff can have
slight differentiation from from instance to instant. Yes, so that
(36:39):
ends up being a bit of a complication. But then
on top of that, you've got the complication of that
where people and we have to figure out how to
handle this new, relatively new discipline and uh. And so
that's why it's so complicated, partially because we made it
that way. But this was really interesting to look into.
I really learned a lot as I started to research
(37:01):
this stuff that you know, I thought I knew, and
then as I was reading, I'm like, wow, I had
a complete Uh, I had the wrong perspective on this.
You know, this topic makes me think that in the future,
we should maybe do an episode entirely devoted to the
future of medical research incentives, because the whole the thinking
behind the patent system, as you said earlier, you know,
(37:23):
part of it is about in the long term, sharing information,
but it's also about providing incentive for research. Right is
saying that it's sort of giving you a guarantee that
if you forge a path that is a productive path,
you will reap rewards from it, and other people can't
scoop your rewards away. Um, And so I wonder, I
(37:45):
wonder if they're interesting trains of thought about what types
of incentives for research will continue into the future. I mean,
will you always have to have the same kind of
promise from the market to make people invest the time
and money into life saving research. Well, and we could
also have an interesting discussion about Salk and the polio vaccine,
(38:10):
because there's the the infamous exchange where he developed the
polio vaccine and he was asked who holds the patent
on it? And he says, well, I I suppose the
people hold the patent on it. I mean, would you
patent the sun? And so there are people who champion
him as saying that this was a person who developed
a uh an approach to stave off a devastating disease
(38:35):
for the good of all humans, right, like an altruistic act,
And the truth of the matter gets a little more
muddy and complicated. But that would be a great side
discussion for that particular episode, I would say, so keep
an ear out for that in the future. Meanwhile, make
sure that you go and check out the videos we've
(38:56):
been doing for Forward Thinking this season. I think that
there's some of the strong ones we've produced so far.
And uh if you have any suggestions for future episodes,
or you have a question about something we've talked about
in the past, send it our way. The email addresses
f W Thinking at how Stuff Works dot com, or
you can drop us the line on Twitter where FW
(39:16):
thinking there, or search FW Thinking and Facebook. Our profile
will pop up. You can leave us a message and
we will talk to you again really soon. For more
on this topic in the future of technology, visit forward
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