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Mylan, Biocon get CRL for Neulasta biosimilar

By Jennifer Boggs
Managing Editor

Tuesday, October 10, 2017

Biocon Ltd. said Tuesday the FDA issued a complete response letter for partner Mylan NV's BLA for MYL-1401H, a proposed biosimilar of Amgen Inc.'s Neulasta, the latest biosimilar version of the long-acting G-CSF drug to hit a regulatory snag.

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