FDA Accepts Dr Reddy’s 351(k) BLA for Proposed Interchangeable Abatacept Biosimilar

FDA Accepts Dr Reddy’s 351(k) BLA for Proposed Interchangeable Abatacept Biosimilar

By, Admin 24 February 2026

Dr. Reddy's Laboratories has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its 351(k) Biologics License Application (BLA) for DRL_AB, a proposed interchangeable biosimilar to Orencia (abatacept).

The IV infusion formulation BLA was submitted in December 2025, and its acceptance marks a key regulatory milestone in Dr Reddy’s biosimilars programme.

Indications (If Approved)

Once approved, DRL_AB IV infusion is intended for the treatment of:

  • Adults with moderately-to-severely active rheumatoid arthritis (RA)
  • Adults with active psoriatic arthritis (PsA)
  • Patients aged six years and older with moderately-to-severely active polyarticular juvenile idiopathic arthritis (pJIA)

Abatacept is a biologic therapy that modulates T-cell activation and is widely used in autoimmune inflammatory conditions.

Regulatory and Clinical Development

The 351(k) BLA submission includes a comprehensive package of:

  • Analytical similarity data
  • Pharmacokinetic (PK) studies
  • Clinical trial data

Key Studies

  • Phase 1 study (AB-01-003) demonstrated pharmacokinetic similarity to Orencia, with comparable safety and immunogenicity profiles.
  • Phase 3 study (AB-01-004) is ongoing and is designed to compare the efficacy and safety of DRL_AB with the reference product.

If approved as an interchangeable biosimilar, DRL_AB could potentially be substituted for the reference product at the pharmacy level, subject to state laws, enhancing patient access.

Strategic Significance

Milan Kalawadia, CEO – North America, Dr Reddy’s Laboratories, described the submission as a significant milestone, noting that the company believes it is the first to file a BLA for an abatacept biosimilar.

The development reflects Dr Reddy’s continued investment in in-house biologics capabilities and its strategy to expand access to high-quality, cost-effective biologic therapies in the United States.

Expanding Biosimilar Competition in Immunology

Acceptance of the BLA for review does not guarantee approval, but it initiates the FDA’s formal evaluation process. If approved, DRL_AB would add to the growing U.S. biosimilars landscape in immunology — a therapeutic area characterized by high biologic treatment costs and long-term patient use.

For patients with chronic autoimmune diseases, additional biosimilar options may help improve affordability and broaden treatment access.

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