India Pharma Outlook Team | Monday, 23 February 2026
Dr. Reddy’s Laboratories Ltd. announced today that the US Food and Drug Administration has accepted for review its 351(k) Biologics License Application (BLA) for DRL_AB, a proposed interchangeable abatacept biosimilar to ORENCIA (abatacept).
The application for the IV infusion formulation was submitted in December 2025, marking a key step forward for the company’s biologics portfolio in the United States.
“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.
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“We look forward to working with the FDA to bring this in-house developed biosimilar to market as a cost-effective alternative for patients and healthcare providers in the United States.”
If approved, DRL_AB will be administered as an IV infusion for adults with moderately-to-severely active rheumatoid arthritis, adults with active psoriatic arthritis, and patients aged six years and older with moderately-to-severely active polyarticular juvenile idiopathic arthritis. The abatacept biosimilar submission includes a comprehensive package of analytical, pharmacokinetic, and clinical data.
The Phase 1 study (AB-01-003) demonstrated pharmacokinetic similarity, along with comparable safety and immunogenicity profiles to ORENCIA. A pivotal Phase 3 study (AB-01-004) evaluating efficacy and safety against ORENCIA is currently ongoing.
