Lupin gets USFDA acceptance for Pegfilgrastim Biosimilar application

02 Jun 2021 Evaluate

Lupin has declared that the USFDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway. Pegfilgrastim has estimated annual sales of $ 3.66 billion in the U.S. (IQVIA MAT December 2020).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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