Lupin gets US FDA nod for its first biosimilar drug Pegfilgrastim

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Drugmaker Lupin has received approval from the US Food and Drug Administration (US FDA) for Armlupeg (pegfilgrastim-unne) drug, a medication used to lower the risk of infection in patients undergoing certain types of chemotherapy or exposed to high doses of radiation.

 

This marks the company’s first biosimilar clearance in the world’s largest pharma market.

 

The product, a biosimilar to Amgen’s popular drug Neulasta, will be manufactured at Lupin’s biotech facility in Pune, which underwent a successful US FDA inspection prior to approval.

 

Armlupeg, a 6 mg/0.6 mL prefilled syringe for subcutaneous injection, is indicated to reduce the incidence of febrile neutropenia, the development of a fever alongside other signs of infection in patients with non-myeloid cancers receiving myelosuppressive chemotherapy. It is also approved for increasing survival in patients exposed to myelosuppressive doses of radiation.

 

Pegfilgrastim products generated estimated annual sales of $1.29 billion in the US for the 12 months ended September 2025, according to IQVIA data.

 

Calling the approval a “pivotal milestone”, Lupin CEO Vinita Gupta said the company is accelerating its biosimilar ambitions to offer affordable and accessible therapies to US patients. “We look forward to introducing a robust portfolio of biosimilars over the next few years,” she said.

 

Lupin MD Nilesh Gupta noted that the company’s integrated biologics capabilities from cell-line development to process optimisation and clinical development have positioned it strongly in the global biosimilars market. “Our biologics facility is now approved by every major regulator, enabling us to deliver high-quality biosimilars at scale,” he said.

 

Lupin, headquartered in Mumbai, operates across more than 100 markets with a portfolio spanning branded generics, complex generics, biotechnology products and APIs. The company has 15 manufacturing sites and seven R&D centres globally, supported by a workforce of over 22,000 employees.