USFDA approves Dr.’s license application Reddy for a biosimilar of Orencia good

The U.S. Food and Drug Administration (USFDA) has approved a Biologics License Application (BLA) for a proposed biosimilar for Orencia (abatacept).

The company’s 351(k) Biologics License Application (BLA) IV for infusion formulation for DRL-AB, for the proposed interchangeable biosimilar, was submitted in December 2025.

“We are proud to be the first to submit a BLA for a biosimilar of abatacept, marking an important milestone in our mission to increase patient access to critical, high-quality biologic therapies,” said Milan Kalawadia, CEO, North America, Dr. Reddy’s in a press release on Saturday.

“We look forward to working with the FDA to bring this proprietary biosimilar to market as a cost-effective alternative for patients and healthcare providers in the United States.”

DRL-AB, once approved, will be administered as an IV infusion formulation for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), and individuals aged six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Hyderabad-based Dr. Reddy’s application included an extensive data package comprising analytical, pharmacokinetic (PK) and clinical studies.

Published on February 21, 2026