On February 20, 2026 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s"), reported 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.

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"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 Clinical Milestones:

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 [ongoing].
About DRL_AB

DRL_AB is a proposed biosimilar to Orencia (abatacept) IV for infusion, a selective co-stimulation modulator, inhibits T-cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. Activated T lymphocytes are implicated in the pathogenesis of RA, pJIA and PsA and are found in the synovium of patients with RA, pJIA and PsA.

References: Orencia (abatacept) Prescribing Information
View Source

*Dr. Reddy’s DRL_AB is not currently seeking approval for prophylactic treatment of aGVHD.

The reference product, Orencia (abatacept), is a registered trademark owned by Bristol-Myers Squibb Company.

RDY-0226-BIO

(Press release, Dr Reddy’s, FEB 20, 2026, View Source [SID1234662825])