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FDA accepts Mylan’s BLA for biosimilar pegfilgrastim

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Mylan N.V. and Biocon Ltd. said the FDA has accepted Mylan’s Biologics License Application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. The FDA goal date set under the Biosimilar User Fee Act is Oct. 9.

The proposed biosimilar pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.

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