Lupin Gets FDA Approval for Biosimilar Armlupeg
Lupin declared that the U.S. Food and Drug Administration (FDA) has authorized Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous administration in a single-dose prefilled syringe, as a biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection.
The product will be produced at Lupin's Biotech plant in Pune, which underwent inspection by the U.S. FDA before receiving approval.
Armlupeg is recommended to reduce the occurrence of infection, evidenced by febrile neutropenia, in individuals with nonmyeloid malignancies undergoing treatment with myelosuppressive anti-cancer medications linked to a clinically relevant rate of febrile neutropenia. It also enhances survival in patients who are acutely exposed to myelosuppressive levels of radiation.
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"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," says Vinita Gupta, CEO, Lupin.
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Nilesh Gupta, MD, Lupin says, "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," says Dr. Cyrus Karkaria, President, Biotechnology, Lupin.
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Pegfilgrastim 6 mg/0.6 mL injection for subcutaneous administration in a single-use prefilled syringe had projected yearly revenue of $ 1,295 million in the U.S. for the year ending September 2025.