Lupin gains FDA approval for biosimilar Armlupeg

Lupin Limited announced on December 1, 2025, that the U.S. Food and Drug Administration (FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use. This single-dose prefilled syringe is approved as a biosimilar to Neulasta® (pegfilgrastim) and will be manufactured at Lupin's Biotech facility in Pune, following a successful FDA inspection. This approval marks Lupin's first biosimilar to achieve FDA approval.

Armlupeg™ is indicated to decrease the incidence of infection, manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. The approved biosimilar references a market with estimated annual sales of $1,295 million in the U.S. for the 12 months ending September 2025 (IQVIA MAT).

Company chief executive Vinita Gupta highlighted the approval as a pivotal step in Lupin's commitment to providing affordable and accessible medicines in the U.S. managing director Nilesh Gupta emphasized the company's integrated biologic capabilities and state-of-the-art facility, ensuring adherence to global quality standards and affordability.