Dr. Reddy's says FDA accepted abatacept biosimilar BLA for review
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
Dr. Reddy's Laboratories said the U.S. Food and Drug Administration has accepted for review its 351(k) Biologics License Application for the IV for infusion formulation of DRL_AB, a proposed interchangeable biosimilar to ORENCIA (abatacept). The application was submitted in December 2025 and includes a comprehensive data package consisting of analytical, pharmacokinetic, and clinical studies.
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, adults with active psoriatic arthritis, and individuals aged six years and above with moderately-to-severely active polyarticular juvenile idiopathic arthritis.
The company said the submission includes results from the Phase 1 study AB-01-003, which achieved pharmacokinetic similarity with comparable safety and immunogenicity profiles with Orencia. It also cited the pivotal Phase 3 study AB-01-004, to compare the efficacy and safety of DRL_AB with Orencia, as ongoing.