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News Details

01/12/2025 11:34

Lupin gets USFDA approval for Pegfilgrastim Biosimilar

Lupin announced on Monday that it has received approval from the US Food and Drug Administration (USFDA) for its biosimilar Armlupeg (pegfilgrastim-unne), used to treat neutropenia in cancer patients.

The approved product — a 6 mg/0.6 mL prefilled syringe for subcutaneous use — is a biosimilar to Neulasta (pegfilgrastim).

Lupin said the biosimilar will be manufactured at its Pune biotech facility, which recently underwent a USFDA inspection prior to approval.