Ep 2- How Are Biosimilars Approved?

Biosimilar medications must still win approval by the U.S. Food and Drug Administration. In this episode, co-hosts Zoe Rothblatt and Conner Mertens explore that approval process, and explain the unique naming convention the FDA came up with for biosimilars.

“They were really, really driven to understand how their naming convention was being used. And I think that’s pretty admirable, that it’s not just that you’re putting out this standard and saying, ‘This is the standard and you have to follow it'," says Criswell Lavery, Clinical Research Coordinator, University of Pennsylvania

Among the highlights in this episode:

2:15 – Getting biosimilars approved – the abbreviated pathway

3:55 – Why biosimilars have strange names – and why those names have safety implications

5:37 – Working with the FDA on the approval process

10:13 – Extrapolation, and how it can potentially bring down costs for patients

11:59 – What’s ‘interchangeability’ all about?

14:23 – The FDA approves the first biosimilar as interchangeable

Contact Our Hosts:

Zoe Rothblatt, Patient Advocate and Community Outreach Manager at GHLF. [e-mail]

Conner Mertens, Patient Advocate and Community Outreach Manager at GHLF. [e-mail]

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