Indian pharmaceutical major Lupin has received approval from the US Food and Drug Administration (US FDA) for Armlupeg (pegfilgrastim-unne), marking a historic milestone as the company’s first biosimilar approval in the United States — the world’s largest pharmaceutical market.
Armlupeg is a biosimilar to Amgen’s blockbuster drug Neulasta and will be manufactured at Lupin’s state-of-the-art biotech facility in Pune, which recently completed a successful US FDA inspection ahead of the approval.
About Armlupeg
Armlupeg is supplied as a 6 mg/0.6 mL prefilled syringe for subcutaneous injection and is indicated for:
- Reducing the incidence of febrile neutropenia in patients with non-myeloid cancers undergoing myelosuppressive chemotherapy
- Increasing survival in patients exposed to myelosuppressive radiation doses
Pegfilgrastim products generated an estimated $1.29 billion in annual US sales in the 12 months ending September 2025, according to IQVIA.
Leadership Welcomes a Major Milestone
Lupin Chief Executive Officer Vinita Gupta called the approval a “pivotal milestone”, highlighting that the company is accelerating its biosimilar strategy to deliver affordable and accessible therapies to patients in the US market.
“We look forward to introducing a robust portfolio of biosimilars over the next few years,” she added.
Managing Director Nilesh Gupta said the achievement reflects Lupin’s strength across the biologics value chain — from cell-line development and process optimisation to clinical development.
“Our biologics facility is now approved by every major regulator, enabling us to deliver high-quality biosimilars at scale,” he noted.
Boost to Lupin’s Biosimilar Strategy
The US approval is expected to significantly strengthen Lupin’s position in the global biologics and biosimilar market. The company has been expanding its branded generics and specialty drug offerings while building a strong pipeline of advanced therapies for highly regulated markets.
Headquartered in Mumbai, Lupin operates in over 100 countries with a portfolio spanning branded generics, complex generics, biotechnology products and active pharmaceutical ingredients (APIs). Its global footprint includes 15 manufacturing sites and seven R&D centres, supported by more than 22,000 employees.