Hyderabad: In a significant regulatory development, Dr Reddy’s USFDA BLA Acceptance for its proposed interchangeable biosimilar, Abatacept (DRL_AB), has been announced following the United States Food and Drug Administration’s review confirmation.
Dr. Reddy’s Laboratories Ltd. stated that the U.S. Food and Drug Administration has accepted for review its 351(k) Biologics License Application (BLA) for the IV infusion formulation of DRL_AB, submitted in December 2025.
The Dr Reddy’s USFDA BLA Acceptance pertains to DRL_AB, a proposed interchangeable biosimilar to Orencia (abatacept) IV for infusion. The BLA submission is supported by a robust data package demonstrating similarity through the totality of evidence, including pharmacokinetic (PK) data.
Regulatory Review of DRL_AB Under 351(k) Pathway
The Dr. Reddy’s USFDA BLA Acceptance follows the submission of a 351(k) Biologics License Application for DRL_AB, which is being developed as a proposed interchangeable biosimilar to Orencia (abatacept) IV formulation.
The 351(k) pathway enables the review and approval of biosimilars based on comprehensive analytical, non-clinical, and clinical data demonstrating similarity to the reference product.
“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.”
The Dr. Reddy’s USFDA BLA Acceptance marks an important step in the regulatory process as the company continues engagement with the FDA during the review period.
Also Read: Biopharma SHAKTI Announced in Union Budget 2026-27 with ₹10,000 Crore Outlay
Indications and Administration of DRL_AB
Upon approval, DRL_AB will be administered as an IV infusion formulation for the treatment of:
- Adults with moderately-to-severely active rheumatoid arthritis (RA)
- Adults with active psoriatic arthritis (PsA)
- Individuals aged six years and above with moderately-to-severely active polyarticular juvenile idiopathic arthritis (pJIA)
The Dr. Reddy’s USFDA BLA Acceptance covers indications aligned with the reference biologic Orencia (abatacept), which is used in autoimmune inflammatory conditions.
The submission includes a comprehensive data package comprising analytical studies, pharmacokinetic (PK) studies, and clinical trial data.
Dr Reddy’s USFDA BLA Acceptance: Clinical Development Milestones
The Dr. Reddy’s USFDA BLA Acceptance is supported by multiple clinical milestones achieved during the development of DRL_AB:
- Phase 1 Study (AB-01-003): Achieved pharmacokinetic similarity with comparable safety and immunogenicity profiles to Orencia.
- Pivotal Phase 3 Study (AB-01-004): Designed to compare the efficacy and safety of DRL_AB with Orencia (ongoing).
These studies form part of the totality-of-evidence framework submitted as part of the 351(k) BLA.
Also Read: Symbiosis Medtronic Experience Centre Launched in Pune to Advance Clinical Training
About DRL_AB and Mechanism of Action
DRL_AB is a proposed biosimilar to Orencia (abatacept) IV for infusion. Abatacept is 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 rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and psoriatic arthritis (PsA), and are found in the synovium of patients with these conditions.
With the Dr. Reddy’s USFDA BLA Acceptance, the proposed interchangeable biosimilar DRL_AB advances into the regulatory review phase in the United States.
