Neulasta biosimilar BLA accepted by FDA

Netherlands-incorporated generics major Mylan (Nasdaq: MYL) and Indian drugmaker Biocon (BSE: 532523) have had their Biologics License Application (BMA) for a second biosimilar accepted by the US Food and Drug Administration (FDA).

The latest filing they have had accepted is a proposed biosimilar to Neulasta (pegfilgrastim), from US biotech major Amgen (Nasdaq: AMGN), which is used to reduce the duration of neutropenia and the incidence of associated fever in adult patients treated with chemotherapy in certain types of cancer.

"Our proposed biosimilar pegfilgrastim will expand our oncology portfolio and further enable us to fulfil our promise of making cancer care affordable and accessible for patients across the globe"