Lupin secures USFDA nod for biosimilar Armlupeg
Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection.
The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval.
Armlupeg is indicated for:
Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non- myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation.
“We are proud to achieve the FDA approval for our first biosimilar, Pegfilgrastim. This step marks a pivotal step in Lupin’s ongoing commitment to providing more affordable, accessible medicines to U.S. patients. We look forward to introducing a robust portfolio of biosimilars over the next few years, which will help improve the quality of care for the communities and patients we serve,” said Vinita Gupta, CEO, Lupin.
Nilesh Gupta, MD, Lupin, said, “Our integrated biologic capabilities encompass the entire spectrum, from initial cell line development to upstream/downstream process optimization and clinical development. This, coupled with our state-of-the-art biologic facility that has now been approved by every major regulatory body, ensures that we deliver biosimilars that meet the highest global quality standards while achieving the scale necessary for global affordability."
"We are pleased to have obtained approval for Pegfilgrastim. This milestone demonstrates Lupin’s unwavering commitment to reducing barriers to treatment and empowering patients with greater choice and confidence in their healthcare journey,” said Dr. Cyrus Karkaria, President, Biotechnology, Lupin.
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).
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