The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MYL-1401H (Mylan and Biocon), a proposed biosimilar candidate to Amgen’s Neulasta (pegfilgrastim).

The proposed Neulasta biosimilar is indicated for the reduction of the duration of neutropenia and the incidence of neutropenia-associated fever in patients treated with chemotherapy in certain cancer types. MYL-1401H was evaluated in efficacy, safety, pharmacokinetic and pharmacodynamic studies comparing it to Neulasta.  

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The FDA has set a Biosimilar User Fee Act (BsUFA) target date of Oct. 9, 2017 to make a decision on the BLA.

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