FDA Accepts Dr. Reddy's Application for Orencia Biosimilar

Dr. Reddy's Laboratories has received FDA acceptance for its marketing application for a biosimilar of Orencia, a leading arthritis treatment from Bristol-Myers Squibb. The biosimilar, DRL_AB, is designed for intravenous use in adults with conditions like rheumatoid and psoriatic arthritis. This marks the first U.S. application for an off-patent version of Orencia.

The company submitted its 351(k) Biologics License Application in December 2025, becoming the first to seek U.S. approval for an off-patent version of Orencia. If approved, the product will be available as an intravenous infusion for rheumatoid arthritis and psoriatic arthritis patients.

Dr. Reddy's aims for DRL_AB to achieve interchangeable status, which, if granted, would allow the drug to be substituted at the pharmacy level without the need for the prescribing healthcare provider's intervention. The proposed IV formulation targets the treatment of adults suffering from moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, and children over six with moderately-to-severely active polyarticular juvenile idiopathic arthritis, once it receives approval.

In 2025, Orencia brought in $2.7 billion in revenue for Bristol-Myers Squibb, reflecting a ~1% year-over-year decline, yet demonstrating robust market demand. Dr. Reddy's biosimilar could directly compete in this lucrative market if approved.

The application is supported by thorough studies including analytical, pharmacokinetic, and clinical data. Dr. Reddy's Laboratories Ltd is one of the largest generic drug manufacturers globally, with a significant presence in North America, which accounts for approximately half of its generics sales. The company also has a strong foothold in India, Russia, and several European and Latin American countries. Beyond generics, Dr. Reddy's boasts a robust portfolio of injectables, contributing 25% to its North American sales.