Dr. Reddy’s Abatacept BLA Accepted for USFDA Review (2026)

USFDA review acceptance for DRL_AB

Dr. Reddy’s Laboratories said the US Food and Drug Administration (USFDA) has accepted for review its 351(k) Biologics License Application (BLA) for DRL_AB, an IV for infusion formulation. The filing is for a proposed interchangeable biosimilar to Orencia (abatacept) IV for infusion. The company said the BLA was submitted in December 2025. USFDA acceptance means the application has cleared an initial completeness check and will move into a substantive review process. Dr. Reddy’s positioned the filing as part of its push to expand access to biologic therapies in the United States.

What Dr. Reddy’s said about the filing

Milan Kalawadia, CEO, North America at Dr. Reddy’s, said the company was “proud to be the first to submit a BLA for an abatacept biosimilar,” calling it a milestone tied to improving patient access to high-quality biologic therapies. He added that Dr. Reddy’s looked forward to working with the FDA to bring the in-house developed biosimilar to market as a cost-effective alternative for patients and healthcare providers in the United States. The company’s statement is aligned with how biosimilar makers typically frame US launches, but the update itself is limited to the USFDA review acceptance and the data package supporting the application. Dr. Reddy’s did not share a target action date or launch timeline in the provided text.

Product details: DRL_AB and the reference medicine

DRL_AB is described as a proposed biosimilar to Orencia (abatacept) IV for infusion. Orencia is a selective co-stimulation modulator that inhibits T-cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Dr. Reddy’s filing covers the IV for infusion formulation. The company also clarified that DRL_AB is not currently seeking approval for prophylactic treatment of aGVHD.

Proposed indications and patient groups

Dr. Reddy’s said DRL_AB, once approved, will be administered as an IV for infusion for multiple inflammatory conditions. These include adults with moderately-to-severely active rheumatoid arthritis (RA) and adults with active psoriatic arthritis (PsA). It also covers individuals aged six years and above with moderately-to-severely active polyarticular juvenile idiopathic arthritis (pJIA). The company’s statement focuses on these patient segments, which are consistent with abatacept’s established use in immune-mediated diseases.

What the BLA is based on

The company said its 351(k) BLA submission includes a comprehensive data package consisting of analytical, pharmacokinetic (PK), and clinical studies. It also described the dossier as supporting similarity to Orencia IV for infusion through the “totality of evidence,” including PK data. While no study datasets or numerical results were included in the text, the emphasis is on similarity evidence, which is central to biosimilar review pathways. For an interchangeable biosimilar, regulators also evaluate switching and related evidence, but the provided text only explicitly mentions the robustness of the package and PK support.

Clinical programme: Phase 1 and ongoing Phase 3

Dr. Reddy’s listed two studies supporting the programme for DRL_AB.

• Phase 1 study AB-01-003 achieved pharmacokinetic similarity with comparable safety and immunogenicity profiles versus Orencia.
• Pivotal Phase 3 study AB-01-004 is designed to compare efficacy and safety of DRL_AB with Orencia and is ongoing.

The company did not provide interim Phase 3 findings, timelines for completion, or whether any switching components are included, beyond the statement that the Phase 3 study is ongoing.

Key facts snapshot

How this fits Dr. Reddy’s biosimilars track record

Dr. Reddy’s described itself as a global pharmaceutical company headquartered in Hyderabad, India, and referenced recent biosimilar activity. The text notes a launch of pegfilgrastim in the U.S. and Europe through a partner. It also said the company launched its rituximab biosimilar in Europe in 2025. These references provide context on the company’s intent to build a regulated-market biosimilars presence, even as products and geographies differ by partnership model and regulatory progress.

Regulatory context from the rituximab experience

The provided material also includes earlier regulatory developments for Dr. Reddy’s proposed rituximab biosimilar, DRL_RI. On April 20, 2024, the company said the FDA issued a Complete Response Letter (CRL) for its BLA for biosimilar rituximab, referencing regulatory inspections at Dr Reddy’s Biologics facility in 2023 and “certain aspects pertaining to the BLA.” Separately, in April 2024, the US District Court for the District of New Jersey dismissed all patent infringement claims brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s and Fresenius Kabi related to Dr Reddy’s rituximab, following a settlement. The text also notes that the FDA had accepted for review Dr. Reddy’s BLA for DRL_RI on July 12, 2023.

Market impact: what investors should track from here

The immediate update for DRL_AB is procedural but important: the regulator has accepted the abatacept biosimilar BLA for review, following the December 2025 submission. From a business perspective, the statement highlights that Dr. Reddy’s is pursuing an interchangeable biosimilar positioning and is advancing an in-house developed biologic candidate for the U.S. market. For investors tracking the biosimilars pipeline, the key watch points in the text are the ongoing pivotal Phase 3 study AB-01-004, and the FDA’s review outcome on the submitted 351(k) BLA. Dr. Reddy’s has not provided guidance on timelines, expected approval windows, or commercial launch timing in the disclosed material.

Conclusion

Dr. Reddy’s said the USFDA has accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar of Orencia (abatacept) IV for infusion, submitted in December 2025. The company’s submission is supported by analytical, PK and clinical studies, including a Phase 1 study showing PK similarity and an ongoing pivotal Phase 3 trial comparing efficacy and safety. The next confirmed step is the USFDA’s substantive review of the application, while the Phase 3 programme continues as described by the company.