The biosimilar insulins are coming

Posted by Scott Kniaz on Wed, Apr 15, 2020

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

March 23, 2020 was a big day for the U.S. insulin market and manufacturers. This day marked the historic completion of the 10-year transition period of certain biologic products, including insulin and human growth hormone, from one regulatory and approval pathway to another. This might sound like nothing more than bureaucratic jargon, but it’s actually very significant, because while insulins have always been biological products, they haven’t always been regulated as such by the FDA. Now that this transition period is over, they will be, increasing competition in a number of different ways. This is all good news for patients, because it’ll drive down prices without, we believe, an impact on innovation.


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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 After releasing its draft guidance more than two years ago, and following a lengthy comment period, the FDA issued the long-awaited document on May 10th.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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