Lupin Gains USFDA Approval for New Cancer Biosimilar

Lupin secures USFDA approval for Armlupeg, a biosimilar indicated for treating neutropenia in cancer patients. The drug, produced at Lupin’s Pune facility, offers a cost-effective alternative to Neulasta. Lupin aims to expand its biosimilar portfolio, enhancing healthcare accessibility in the US market.

Lupin announced on Monday that it has received approval from the US Food and Drug Administration (USFDA) for its biosimilar product aimed at treating neutropenia in cancer patients.

The approved drug, Armlupeg, is a biosimilar to Neulasta and represents a significant step in providing affordable medication to US patients, according to a company statement.

Vinita Gupta, CEO of Lupin, emphasized the company's commitment to introducing a robust portfolio of biosimilars, with Armlupeg marking the beginning of this initiative.

(With inputs from agencies.)