6 months ago
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Drugmaker Lupin has received U.S. Food and Drug Administration support for Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL injection arsenic biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection.
The merchandise volition beryllium manufactured astatine the company’s biotech installation successful Pune, which was inspected by the U.S. FDA anterior to approval, Lupin said connected Monday.
“We are arrogant to execute the FDA support for our archetypal biosimilar, Pegfilgrastim... a pivotal measurement successful Lupin’s committedness to providing much affordable, accessible medicines to U.S. patients. We look guardant to introducing a robust portfolio of biosimilars implicit the adjacent fewer years,” CEO Vinita Gupta.
Armlupeg is indicated for alteration successful the incidence of corruption successful patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically important incidence of febrile neutropenia. It increases endurance successful patients acutely exposed to myelosuppressive doses of radiation, the institution said.
Pegfilgrastim 6 mg/0.6 mL injection, for subcutaneous usage successful a single-dose prefilled syringe, had estimated yearly income of $1,295 cardinal successful the U.S. for the 12 months ended September 2025, Lupin said citing IQVIA MAT numbers.
The company’s “integrated biologic capabilities encompass the full spectrum, from archetypal compartment enactment improvement to upstream/downstream process optimisation and objective development,” MD Nilesh Gupta said.
