Amgen catches a break as FDA rejects Neulasta knockoff; Zafgen gets a new CEO as Hughes moves to top science job
→ Amgen caught a break today on its blockbuster franchise drug Neulasta. The FDA has rejected an application from Biocon and Mylan for a knockoff of the biologic after citing manufacturing issues at the Indian company that need to be resolved. Novartis was recently handed a CRL for its biosimilar of Neulasta as well, conserving a multibillion-dollar market for Amgen. Biocon, though, says it doesn’t expect a delay in its commercial launch plans.
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