Dr Reddy’s Laboratories has announced that the US Food and Drug Administration (USFDA) has accepted for review its 351(k) Biologics License Application (BLA) for infusion formulation for DRL_AB, a proposed interchangeable biosimilar to ORENCIA (abatacept). The application 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 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 data package comprising analytical, pharmacokinetic (PK), and clinical studies.