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4 Jun 2021

Lupin received US FDA biosimilar approval of pegfilgrastim

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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)

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