Drugmaker Lupin has received U.S. Food and Drug Administration approval for Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL injection as biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection.
The product will be manufactured at the company’s biotech facility in Pune, which was inspected by the U.S. FDA prior to approval, Lupin said on Monday.
“We are proud to achieve the FDA approval for our first biosimilar, Pegfilgrastim… a pivotal step in Lupin’s 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,” CEO Vinita Gupta.
Armlupeg is indicated for decrease in the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It increases survival in patients acutely exposed to myelosuppressive doses of radiation, the company said.
Pegfilgrastim 6 mg/0.6 mL injection, for subcutaneous use in a single-dose prefilled syringe, had estimated annual sales of $1,295 million in the U.S. for the 12 months ended September 2025, Lupin said citing IQVIA MAT numbers.
The company’s “integrated biologic capabilities encompass the entire spectrum, from initial cell line development to upstream/downstream process optimisation and clinical development,” MD Nilesh Gupta said.
Published – December 01, 2025 11:52 pm IST
