Lupin received US FDA biosimilar approval of pegfilgrastim

Global pharma major, Lupin Limited (Lupin) today announced that the U.S. FDA 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 USD 3.66 billion in the U.S.

Here are some of the other approved biosimilar of pegfilgrastim.

We are pleased to receive U.S. FDA acceptance of our Biologics License Application for #Pegfilgrastim Biosimilar. #Biosimilars is a key part of our growth strategy and this milestone will help us expand our #oncology portfolio.#Press #LupinInNews

https://t.co/CT62Zf2a14 pic.twitter.com/uBK1qNraLM

— Lupin (@LupinGlobal) June 3, 2021

Biopharmaceutical Project Management