Dr. Reddy’s Laboratories Ltd. announced that the US Food and Drug Administration (USFDA) has accepted for review, its 351 (k) Biologics License Application (BLA) IV for infusion formulation for DRL_AB, a proposed interchangeable biosimilar to ORENCIA (abatacept) that was submitted in December 2025.

“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.

“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.”

DRL_AB, once approved will be administered as an IV for 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 above with moderately-to-severely active polyarticular juvenile idiopathic arthritis (pJIA). The 351 (k) BLA submission includes a comprehensive data package consisting of analytical, pharmacokinetic (PK), and clinical studies.

DRL_AB’s Phase 1 study (AB-01-003), achieved Pharmacokinetic similarity with comparable safety and immunogenicity profiles with Orencia. Pivotal Phase 3 study (AB-01-004), to compare the efficacy and safety of DRL_AB with Orencia is ongoing.