Lupin has received US Food and Drug Administration (FDA) approval for Armlupeg (pegfilgrastim-unne) 6mg/0.6ml injection in a single-dose prefilled syringe for subcutaneous use as a biosimilar to Neulasta (pegfilgrastim).
The company will manufacture the product at its biotechnology facility in Pune, India, which has undergone a previous FDA inspection.
Armlupeg is indicated to reduce the risk of infection, specifically febrile neutropenia, in patients with non-myeloid cancers undergoing treatment with myelosuppressive anti-cancer drugs linked to a significant chance of developing febrile neutropenia.
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The product is indicated to improve survival rates in individuals who have been acutely exposed to myelosuppressive levels 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 MD Nilesh Gupta stated: “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.”
In May 2025, Lupin signed a licence and supply agreement with SteinCares to commercialise its biosimilar ranibizumab in Latin American markets, excluding Argentina and Mexico.
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