Lupin 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, which was inspected by the U.S. FDA prior to approval.
Armlupeg™ is indicated for:
- Decrease 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.
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation.