Lupin has secured United States Food and Drug Administration’s (USFDA) approval for its 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 the company’s Biotech facility in Pune, which was inspected by the USFDA prior to approval. Armlupeg is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
