Lupin Limited has secured a key regulatory milestone with the U.S. Food and Drug Administration granting approval to Armlupeg™ (pegfilgrastim-unne), the company’s first biosimilar to Amgen’s blockbuster drug Neulasta®. The approval marks a significant step in the Indian pharmaceutical major’s plan to expand its biologics footprint in the United States and increase access to affordable oncology supportive-care treatments.
Armlupeg is approved as a 6 mg/0.6 mL injection in a single-dose prefilled syringe for subcutaneous administration. The drug will be manufactured at Lupin’s biotechnology facility in Pune, India, which recently completed a successful U.S. FDA inspection ahead of the approval. The authorization allows Lupin to enter a highly competitive yet fast-growing therapeutic space, with pegfilgrastim biosimilars contributing substantially to cost reductions in cancer care.
The biosimilar carries two key indications. It is approved to reduce the incidence of infection, manifested as febrile neutropenia, in patients with non-myeloid cancers receiving myelosuppressive chemotherapy. Febrile neutropenia is one of the most serious and potentially life-threatening complications of cancer treatment, often requiring hospitalization and delaying future chemotherapy cycles. Armlupeg is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation, broadening its relevance beyond oncology into emergency preparedness and radiation injury management.
Vinita Gupta, CEO of Lupin, described the approval as a “pivotal step” in the company’s commitment to increasing access to biologic therapies in the U.S. market. “We are proud to achieve FDA approval for our first biosimilar, Pegfilgrastim,” she said. “This milestone reinforces our mission to provide affordable, high-quality medicines to U.S. patients. Over the coming years, we look forward to introducing a robust biosimilars portfolio that can meaningfully improve patient care.”
Lupin Managing Director Nilesh Gupta emphasized the company’s extensive end-to-end biologics capabilities, noting that its operations span early cell line development, upstream and downstream manufacturing optimization, and clinical development. He added that the Pune biologics facility has now been approved by every major global regulatory authority, positioning Lupin to scale biosimilar manufacturing while maintaining international quality benchmarks.
Cyrus Karkaria, President of Biotechnology at Lupin, called the approval further proof of the company’s commitment to expanding patient access. “This milestone demonstrates Lupin’s unwavering dedication to reducing barriers to treatment,” he said. “With Armlupeg, patients and healthcare providers will have greater choice and confidence in their treatment journey.”
According to IQVIA data for the 12-month period ending September 2025, pegfilgrastim prefilled syringe products generated an estimated $1.295 billion in U.S. sales. With biosimilars continuing to gain market share across therapeutic categories, Lupin’s entry into the pegfilgrastim market is expected to intensify price competition and broaden affordability for cancer patients.
Armlupeg’s approval aligns with Lupin’s broader ambition to strengthen its biologics pipeline and establish itself as a competitive player in the global biosimilars landscape. As the company prepares for commercial launch, stakeholders across the oncology community will be watching closely to assess how the new biosimilar influences market dynamics and patient access in the months ahead.