Lupin shares in news as firm's cancer injection gets USFDA nod, more details

Lupin shares are in focus on Monday after the firm announced that it has received approval from the United States Food and Drug Administration (USFDA) for Armlupeg (pegfilgrastim-unne) 6 mg/0.6 ml injection, a biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 ml injection. Armlupeg is intended for subcutaneous use in a single-dose pre-filled syringe and will be manufactured at Lupin's biotech facility in Pune.

The facility underwent inspection by the USFDA prior to the approval. According to the company, 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, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Based on IQVIA MAT data, pegfilgrastim 6 mg/0.6 mL injection in a single-dose prefilled syringe posted estimated annual sales of $1,295 million in the US for the twelve months ending September 2025. Vinita Gupta, CEO of Lupin, stated, "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."

Lupin shares ended the previous trading session 0.4% higher at ₹2,080.5 apiece. The stock has declined 12% so far this year. The company has outlined plans for expanding its biosimilar offering in the coming years, with Armlupeg forming a key part of this strategy. The regulatory inspection and manufacturing at the Pune facility have been highlighted as central to this development.