Drug maker Lupin on Monday said it has received approval from the US health regulator for a biosimilar indicated for the treatment of neutropenia in cancer patients.
The US Food and Drug Administration (USFDA) 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) injection, the Mumbai-based firm said in a statement.
The product will be manufactured at the company's biotech facility in Pune, which was inspected by the USFDA prior to approval, it added.
Armlupeg is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
"This step marks a pivotal step in Lupin's ongoing commitment to providing more affordable, accessible medicines to the US patients. We look forward to introducing a robust portfolio of biosimilars over the next few years, which will help improve the quality of care for the communities and patients we serve," said Vinita Gupta, CEO, Lupin.
As per IQVIA MAT data, Pegfilgrastim 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe had estimated annual sales of USD 1,295 million in the US for the 12 months ending September 2025.
Lupin shares were trading 0.47 per cent down at Rs 2,071.20 apiece on BSE.
The US Food and Drug Administration (USFDA) 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) injection, the Mumbai-based firm said in a statement.
The product will be manufactured at the company's biotech facility in Pune, which was inspected by the USFDA prior to approval, it added.
Armlupeg is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
"This step marks a pivotal step in Lupin's ongoing commitment to providing more affordable, accessible medicines to the US patients. We look forward to introducing a robust portfolio of biosimilars over the next few years, which will help improve the quality of care for the communities and patients we serve," said Vinita Gupta, CEO, Lupin.
As per IQVIA MAT data, Pegfilgrastim 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe had estimated annual sales of USD 1,295 million in the US for the 12 months ending September 2025.
Lupin shares were trading 0.47 per cent down at Rs 2,071.20 apiece on BSE.
