FDA to Review Potential Neulasta Biosimilar

The proposed Neulasta biosimilar is indicated for the reduction of the duration of neutropenia
The proposed Neulasta biosimilar is indicated for the reduction of the duration of neutropenia

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.

For more information call (800) RX-MYLAN or visit Mylan.com.