Lupin has received approval from the U.S. Food and Drug Administration (FDA) for its biosimilar Armlupeg (pegfilgrastim-unne), marking an important milestone in the company’s biologics journey. Armlupeg is a biosimilar to Neulasta (pegfilgrastim), a widely used therapy that helps reduce infection risk in cancer patients undergoing chemotherapy.

The FDA has approved Armlupeg in a 6 mg/0.6 mL single-dose, pre-filled syringe for subcutaneous administration. The product will be manufactured at Lupin’s state-of-the-art biotech facility in Pune, which has recently completed a successful US FDA inspection.

With this approval, Lupin enters the competitive U.S. pegfilgrastim market and strengthens its global biosimilar portfolio. The launch is expected to increase access to cost-effective oncology support therapies and enhance Lupin’s presence in the high-value biologics segment.