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.
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.