Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus
US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.
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Thirty-month stay resulting from Sanofi’s patent lawsuit expires on 18 March 2020, two days before Mylan’s application must receive final approval to avoid getting caught in the transition of insulins from drug to biologic regulation. Pre-approval inspection of Biocon’s manufacturing facility resulted in 12 ‘largely procedural’ observations, company says.
In congressional testimony, outgoing Commissioner Scott Gottlieb says FDA already has "a lot of applications in-house" and robust interest when asked about the 2020 transition of insulin from regulation as a drug to a biologic.
With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.