Lupin Receives FDA Approval for Biosimilar Armlupeg

Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has approved 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 Lupin’s Biotech facility in Pune. Armlupeg™ is indicated for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated for increasing survival in patients acutely exposed to myelosuppressive doses of radiation. Lupin has a robust portfolio of biosimilars lined up for the next few years.