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Basal Insulin

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

Here is a brief preview of this blast: 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.