Keeping Track: Mylan Wins First US FDA Approval For Neulasta Biosimilar, But Lands A CRL For Insulin Glargine; Genentech Nabs Broad Full Approval For Venclexta, PV Indication For Rituxan
Executive SummaryThe latest drug development news and highlights from our US FDA Performance Tracker.
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Genentech reports that Rituxan yields better results over 52 weeks in pemphigus patients than off-label use of CellCept. Principia, meanwhile, unveils positive Phase II data for its pemphigus candidate.
After second complete response letter, Mylan and Biocon have just over six months to resolve manufacturing issues and obtain full approval or face having to resubmit the insulin as a biologics license application.
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.