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
— Lupin (@LupinGlobal) June 3, 2021