Lupin’s Pune Plant Powers Ahead with FDA Approved Armlupeg, Setting New Biosimilar Milestone

Mumbai-based global pharma company Lupin Limited announced regulatory approval from the United States Food and Drug Administration (US FDA) for its biosimilar product Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection. Armlupeg is a biosimilar to Neulasta®, used to reduce infection incidence in cancer patients undergoing chemotherapy. The product will be manufactured at Lupin’s state-of-the-art biotech facility in Pune, India, a site with capabilities meeting multiple international regulatory standards.

This regulatory clearance from the US FDA adds to Lupin’s growing portfolio of biosimilars and exemplifies its commitment to making essential biologic therapies more accessible and affordable worldwide. Lupin’s Pune facility, equipped for advanced biopharmaceutical manufacturing, ensures high quality and compliance with global markets. The biosimilar is offered as a single-dose, prefilled syringe for subcutaneous use, aligning with current therapeutic standards.

Key Highlights:

US FDA approval secured for Armlupeg (pegfilgrastim-unne), a biosimilar to Neulasta®

Manufacturing to take place at Lupin’s biotech facility in Pune, India

Armlupeg is designed to decrease infection risk in patients receiving myelosuppressive chemotherapy

Pune facility is a flagship biotech site with global regulatory approvals (EMA, PMDA, Health Canada)

Demonstrates Lupin’s strategic focus on expanding biosimilar access in regulated markets

Supports global cancer care with affordable, high-quality biologic treatment alternatives

Source: Lupin Limited announcement, US FDA