Lupin gets USFDA nod for billion-dollar biosimilar injection used to treat cancer

Lupin Ltd. on Monday, December 1, announced that the US Food and Drug Administration (USFDA) has approved an injection for treatment of cancer patients.

The US drug regulator has approved the Armlupeg (pegfilgrastim-unne) 6mg / 0.6 ml injection for subcutaneous use in a single-dose pre-filled syringe, as the biosimilar to Neulasta (pegfilgrastim) 6mg / 0.6 ml injection, Lupin said.

The product will be manufactured at Lupin's biotech facility in Pune, which was inspected by the USFDA prior to approval, it added.

Lupin said, 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.

As per the IQVIA MAT data, pegfilgrastim 6 mg / 0.6 mL injection for subcutaneous use in a single-dose prefilled syringe had estimated annual sales of $1,295 million in the US for the 12 months ending September 2025.

"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," Vinita Gupta, the CEO of Lupin, said.

Lupin shares ended the previous session 0.4% up at ₹2,080.5 apiece. The stock has declined 12% this year, so far.

Also Read: HUL Demerger: What happens to the stock ahead of the record date on Friday