Biosimilar Interchangeability: Clarity and Ambiguity in the FDA's Final Guidance

Posted by Scott Kniaz on Wed, Jun 19, 2019

Christina Corridon co-wrote this blog post with Scott Kniaz.

Back in April, we wrote a blog post covering almost everything you needed to know about the hot topic of biosimilar interchangeabilitya special designation that allows pharmacies to substitute a biosimilar for a novel biologic product without the input of the prescribing provider. We also told you why it would continue to be in the news for the remainder of 2019—one reason being because the FDA promised to issue finalized guidance on interchangeability by the end of May. Well, that day has come. After releasing its draft guidance more than two years ago, and following a lengthy comment period, the FDA issued the long-awaited document on May 10th. We’ve had a chance to read it and wanted to save you some time by highlighting the most salient issues.


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Biosimilar Interchangeability: What You Need to Know for 2019

Posted by Scott Kniaz on Mon, Apr 01, 2019

Christina Corridon co-wrote this blog post with Scott Kniaz.

In the hallways and boardrooms we occupy, there is a lot of talk of interchangeability of biosimilars right now. Despite all the conversation, there doesn’t seem to be a consensus opinion about its relative value or worthiness. To help you to be more knowledgeable around the watercooler and to help inform your own opinions, let’s start from the beginning, define some key terms, explain what the interchangeability hub-bub is all about, and detail why it is a hot topic that you are hearing more and more about now. 


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