FDA accepts Dr. Reddy's biosimilar abatacept application for review

Dr. Reddy's Laboratories Ltd. (NYSE: RDY) announced that the U.S. Food and Drug Administration has accepted for review its Biologics License Application for DRL_AB, a proposed biosimilar to Orencia (abatacept) for intravenous infusion.

The company submitted the 351(k) BLA in December 2025. Dr. Reddy's stated it is the first company to submit a BLA for an abatacept biosimilar.

DRL_AB is intended for treatment of adults with moderately-to-severely active rheumatoid arthritis, adults with active psoriatic arthritis, and individuals aged six years and above with moderately-to-severely active polyarticular juvenile idiopathic arthritis.

The BLA submission includes analytical, pharmacokinetic and clinical studies. Dr. Reddy's completed a Phase 1 study that achieved pharmacokinetic similarity with comparable safety and immunogenicity profiles to Orencia. A pivotal Phase 3 study comparing the efficacy and safety of DRL_AB with Orencia is ongoing.

"We are proud to be the first to submit a BLA for an abatacept biosimilar which marks a significant milestone in our mission to increase patient access to critical, high-quality biologic therapies," said Milan Kalawadia, CEO, North America, at Dr. Reddy's.

Abatacept is a selective co-stimulation modulator that inhibits T-cell activation by binding to CD80 and CD86, thereby blocking interaction with CD28. The reference product Orencia is owned by Bristol-Myers Squibb Company.

Dr. Reddy's operates a biologics business with six commercial products marketed in India and some products in more than 30 other countries. The company has several biosimilar products in development for oncology and auto-immune diseases.

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