Mylan Wins Final Patent Dispute vs. Sanofi; Biocon Bs-glargine Final FDA Approval Imminent

Mylan announced the US Patent and Trademark Appeal Board (PTAB) ruled in Mylan’s favor during recent inter partes review (IPR) proceedings. Importantly, Mylan’s outgoing CEO, Heather Bresch, commented, “…with this final victory in hand, we now look forward to working with FDA to complete the regulatory review process and introduce Semglee in the U.S. as soon as possible.” Recall, Mylan/Biocon has disclosed that the FDA action date for their bs-glargine is sometime in June 2020. Below, FENIX provides a brief overview of the PTAB ruling as well as thoughts on the impending approval and launch of the Mylan/Biocon bs-glargine product.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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