Lupin Secures FDA Approval for Armlupeg Biosimilar Drug

Lupin has obtained U.S. FDA approval of Armlupeg, a biosimilar of Neulasta. The product is pegfilgrastim 6mg/0.6ml prefilled injection in a single-dose syringe to be used as a subcutaneous injection.

The manufacturing will be done in the biotech facility of Lupin in Pune that had successfully passed a FDA inspection right before the announcement.

Armlupeg reduces the risk of infection, as febrile neutropenia, in patients with non-myeloid malignant tumors undergoing myelosuppressive chemotherapy. It is also acceptable to enhance the survival of the affected people who have been exposed to large amounts 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…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 … 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.

The commercial importance of the present approval can be seen in the fact that in the United States, pegfilgrastim in a prefilled syringe has achieved approximately US1.29billion sales in the 12 months to September 2025, which demonstrates its commercial importance.