4
Jun
2021
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.
Biosimilar Name | Approval Date | Reference Product |
Nyvepria (pegfilgrastim-apgf) | June 2020 | Neulasta (pegfilgrastim) |
Ziextenzo (pegfilgrastim-bmez) | November 2019 | Neulasta (pegfilgrastim) |
Udenyca (pegfilgrastim-cbqv) | November 2018 | Neulasta (pegfilgrastim) |
Fulphila (pegfilgrastim-jmdb) | June 2018 | Neluasta (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