ABLE Patron Gold Member, Dr Reddy’s Laboratories announced in February 2026 that the USFDA has accepted Dr. Reddy’s 351(k) Biologics License Application (BLA) for Proposed Interchangeable biosimilar Abatacept, DRL_AB (IV for Infusion). The submission was made to the US regulator in December 2025.

BLA is based on a robust data package supporting similarity to Orencia® (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data

"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 Mr. 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."

A company statement said 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: 1. Phase 1 study (AB-01-003), achieved Pharmacokinetic similarity with comparable safety and immunogenicity profiles with Orencia. 2. Pivotal Phase 3 study (AB-01-004), to compare the efficacy and safety of DRL_AB with Orencia [ongoing].

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.

Dr. Reddy's Laboratories is a prominent Indian multinational pharmaceutical company headquartered in Hyderabad, focusing on generic medicines, APIs, biosimilars, and differentiated formulations.