Armlupeg (pegfilgrastim-unne)

Biosimilar

Region: 🇺🇸 US
Active substance: pegfilgrastim-unne
Company: Lupin Ltd
Status: Approved
FDA approval: Fri 28 Nov 2025
Designations: Biosimilar
Application: BLA761212
Official record: www.accessdata.fda.gov

Regulatory milestones

Fri 28 Nov 2025🇺🇸 FDA approval

FDA approves biosimilar Armlupeg (pegfilgrastim-unne)

Lupin Ltd; BLA761212; Biosimilar; injection · source

Follow Armlupeg

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.