USFDA Accepts Dr Reddy's BLA for Interchangeable Orencia Biosimilar
Hyderabad: Dr. Reddy's Laboratories Ltd. has received acceptance from the U.S. Food and Drug Administration to review its 351(k) Biologics License Application (BLA) for DRL_AB, a proposed interchangeable biosimilar to Orencia (abatacept).
The regulatory milestone marks a significant step in the company's biosimilars expansion strategy in the United States.
The BLA, submitted in December 2025, seeks approval for an intravenous (IV) formulation of abatacept, referencing the innovator product marketed by Bristol Myers Squibb. Acceptance of the application indicates that the USFDA has determined the submission is sufficiently complete to permit a substantive review.
If approved, DRL_AB will be indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), and pediatric patients aged six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).
The company stated that its development program includes comprehensive analytical, non-clinical, and clinical data to demonstrate similarity to the reference product in terms of quality, safety, and efficacy. A Phase 1 clinical study confirmed pharmacokinetic similarity along with comparable safety and immunogenicity profiles. A pivotal Phase 3 study evaluating efficacy and safety is currently ongoing.
Commenting on the development, Milan Kalawadia, CEO – North America, Dr. Reddy’s Laboratories, said the submission represents a key milestone in the company’s efforts to expand patient access to high-quality and affordable biologic therapies in the United States. The company expressed its commitment to working closely with the regulator throughout the review process.
Dr. Reddy’s is among the first companies to submit a BLA for an abatacept biosimilar seeking interchangeable status in the US, underscoring its focus on strengthening its biosimilars portfolio in regulated markets.
Founded in 1984 and headquartered in Hyderabad, Dr. Reddy’s operates across generics, active pharmaceutical ingredients (APIs), biosimilars, and over-the-counter products, with a presence in major global markets including the US, Europe, and India.
