Lupin Limited has received U.S. FDA approval for its biosimilar, Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection. This approval marks a pivotal step in Lupin’s biosimilar program, aiming to offer more affordable medicines. The product, a biosimilar to Neulasta®, will be manufactured at Lupin’s Biotech facility in Pune. Lupin aims to introduce a robust portfolio of biosimilars in the coming years.
FDA Approval for Armlupeg™
Lupin Limited (Lupin) announced that the U.S. Food and Drug Administration (FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe. This product is a biosimilar to Neulasta® (pegfilgrastim) 6 mg/0.6 mL injection.
Manufacturing and Indication
The biosimilar will be manufactured at Lupin’s Biotech facility in Pune, which has been inspected by the U.S. FDA. Armlupeg™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Strategic Importance
This approval is a pivotal step in Lupin’s commitment to providing more affordable medicines. Lupin aims to introduce a robust portfolio of biosimilars over the next few years, helping to improve patient care.
Market Opportunity
Pegfilgrastim 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe had estimated annual sales of USD 1,295 million in the U.S. for the 12 months ending September 2025 (IQVIA MAT).
Source: BSE