Dr Reddy’s submits Abatacept Biosimilar BLA to USFDA for review
351(k) Biologics License Application for DRL_AB IV infusion targets rheumatoid arthritis, psoriatic arthritis and pJIA
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.