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 After releasing its draft guidance more than two years ago, and following a lengthy comment period, the FDA issued the long-awaited document on May 10th.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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The Humira Question: Will the Adalimumab Biosimilars Live Up to the Hype?

Posted by Prateek Yadav on Fri, Dec 07, 2018

Prateek Yadav co-wrote this blog post with Christina Corridon, Tucker Herbert, Didier Chicheportiche and Gustavo Poblete.

The biosimilars market in Europe continues to generate buzz as it captures considerable market share from major blockbuster-branded biologics. Most recently, Celltrion's Truxima, a biosimilar of Roche's MabThera (rituximab), captured 32% market share in 18 European countries. Regulatory agencies have also welcomed biosimilars for the promise of the potential cost savings that they bring. Earlier, the U.K.’s National Health Service reported that switching patients from branded drugs to biosimilars and generics led to a savings of £324 million last year.


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Winning Isn’t Easy: What Biopharma Companies Can Do to Find Success in a Crowded Marketplace

Posted by Ross Shahinian on Wed, Feb 07, 2018

Christina Corridon co-wrote this blog post with Ross Shahinian.

In 2017, there were 46 novel drug approvals in the U.S., according to the FDA. However, the majority (67%) of these drug approvals represent later-to-market entrants that will be vying for share in an increasingly competitive landscape. For example, take Verzenio, Lilly’s CDK-inhibitor for HR-positive breast cancer, which was third to market after Pfizer’s Ibrance and Novartis’s Kisqali. Or Steglatro, the Merck and Pfizer fourth-to-market SGLT-2 drug, which came in after Invokana, Farxiga and Jardiance.


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