Wedoany.com Report-Dec.2, Lupin has secured US Food and Drug Administration (FDA) approval for Armlupeg (pegfilgrastim-unne) 6 mg/0.6 ml injection, a biosimilar to Neulasta (pegfilgrastim). The single-dose prefilled syringe is administered subcutaneously.

The injection is indicated to improve survival rates in individuals who have been acutely exposed to myelosuppressive levels of radiation.

Manufactured at Lupin's biotechnology facility in Pune, India – which has previously passed FDA inspection – 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 associated with a clinically significant risk of febrile neutropenia. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Lupin CEO Vinita Gupta stated: "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 Managing Director Nilesh Gupta added: "Our integrated biologic capabilities encompass the entire spectrum, from initial cell line development to upstream/downstream process optimisation and clinical development. This, coupled with our state-of-the-art biologic facility that has now been approved by every major regulatory body, ensures that we deliver biosimilars that meet the highest global quality standards while achieving the scale necessary for global affordability."

The approval represents Lupin's first biosimilar launched in the United States and strengthens its growing presence in complex biologics. In May 2025, the company also entered a licence and supply agreement with SteinCares to commercialise its biosimilar ranibizumab in selected Latin American markets.