India-based drug maker Lupin Ltd announced on December 1 that it has received approval from the FDA for its pegfilgrastim biosimilar Armlupeg (pegfilgrastim-unne).
Armlupeg’s indications include: (1) to 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; and (2) increase survival in patients acutely exposed to myelosuppressive doses of radiation.
This seventh pegfilgrastim biosimilar to reach the US market had an extended journey. First submitted for approval in June 2021, it had received rejections (complete response letters) from the FDA, as recently as November 2024, for unresolved facility inspection issues. The biosimilar will be manufactured at its facility in Pune, India.
In its press release, Vinita Gupta, CEO of Lupin, said, “We are proud to achieve the FDA approval for our first biosimilar, pegfilgrastim. This step marks a pivotal step in Lupin’s ongoing commitment to providing more affordable, accessible medicines to 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.”
Lupin’s website indicates the company has six biosimilars in active development, without specifying which products are under investigation (only LUBT010, a biosimilar of ranibizumab was listed in clinicaltrials.gov).
The pegfilgrastim market has been marked by large variances in average sales price (ASP) over the past couple of years, with pricing currently between $283 (Ziextenxo) and $2,158 (Stimufend) per 6-mg dose. Lupin did not announce pricing at launch for Armlupeg.
