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Lupin’s Pegfilgrastim Biosimilar Accepted By US FDA

Neulasta Rival Faces A Crowded Market With Four Approved Competitors

Executive Summary

Lupin’s first US biosimilar application, for a rival to Neulasta, has been accepted for filing by the FDA. If approved, the product would join an already crowded market for pegfilgrastim in the US.

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Pfizer has pressed on with the launch of a fourth biosimilar pegfilgrastim product, Nyvepria (pegfilgrastim-apgf), according to an investment bank. With Amgen continuing to hold more than 70% of the market, there is opportunity for Pfizer to capture significant market share.

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