US FDA accepts application of Mylan & Biocon for biosimilar pegfilgrastim

Mylan NV and Biocon Ltd today announced that the US Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) 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 (BsUFA) is October 9, 2017. 

Rajiv Malik, president, Mylan, commented, “We are proud of