FDA Accepts Dr. Reddy's BLA for Proposed Interchangeable Abatacept Biosimilar
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
The US Food and Drug Administration has accepted for review Dr. Reddy's Laboratories' 351(k) Biologics License Application for DRL_AB, a proposed interchangeable biosimilar to ORENCIA® (abatacept) IV for infusion formulation, following submission in December 2025. Dr. Reddy's is the first to submit a BLA for an abatacept biosimilar.
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.
The Phase 1 study (AB-01-003) achieved Pharmacokinetic similarity with comparable safety and immunogenicity profiles with Orencia. A pivotal Phase 3 study (AB-01-004) to compare the efficacy and safety of DRL_AB with Orencia is ongoing.
DRL_AB is a proposed biosimilar to Orencia® (abatacept) IV for infusion, a selective co-stimulation modulator that 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 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.
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Over the last 25 years, the company's Biologics team has developed into a fully integrated organization with robust capabilities in the development, manufacture and commercialization of a range of biosimilar products in oncology and immunology. The company has a current portfolio of six commercial products marketed in India, with some products marketed in more than 30 other countries. In 2024, Dr. Reddy's launched its first biosimilar in the United Kingdom, Versavo® (biosimilar bevacizumab), following its launch of pegfilgrastim in the U.S and Europe through a partner. The company also launched its rituximab biosimilar in Europe in 2025.