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.