USFDA Accepts Dr Reddy's Biologics License Application for Orencia Biosimilar
Dr Reddy's Laboratories Ltd has announced a significant development in the pharmaceutical sector. The US Food and Drug Administration (USFDA) has officially accepted for review the company's 351(k) Biologics License Application (BLA) for DRL_AB. This proposed biosimilar is designed to be interchangeable with Orencia (abatacept), a medication administered via intravenous infusion.
Potential Indications and Therapeutic Impact
If the application receives approval from the regulatory authorities, DRL_AB will be indicated for a range of serious arthritic conditions. Specifically, it would target adults suffering from moderately to severely active rheumatoid arthritis. Additionally, it would be used for adults with active psoriatic arthritis. The treatment would also extend to pediatric patients aged 6 years and older who are diagnosed with moderately to severely active polyarticular juvenile idiopathic arthritis.
Mechanism of Action: Abatacept, the active ingredient in Orencia, functions as a selective co-stimulation modulator. It operates by binding to CD80 and CD86 proteins, thereby blocking their interaction with CD28. This inhibition is crucial as it prevents full T-lymphocyte activation, which plays a key role in the inflammatory processes associated with these autoimmune diseases.
Submission Details and Supporting Evidence
The Hyderabad-based pharmaceutical giant submitted this comprehensive application in December 2025. The submission is bolstered by a robust "totality of evidence" package. This package is meticulously crafted to demonstrate the biosimilarity of DRL_AB to the reference product, Orencia IV for infusion. It includes critical data from pharmacokinetic studies, along with extensive analytical and clinical research findings.
Milan Kalawadia, CEO of North America at Dr Reddy's, expressed pride in this milestone. He stated, "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." Kalawadia further emphasized the company's commitment to collaborating with the FDA to introduce this in-house developed biosimilar to the US market. The goal is to provide a cost-effective alternative that benefits both patients and healthcare providers.
Clinical Trial Progress and Safety Profile
Dr Reddy's has provided detailed insights into the clinical milestones achieved for the DRL_AB program. The Phase 1 study, designated as AB-01-003, successfully met its pharmacokinetic similarity objectives. Importantly, this study also demonstrated comparable safety and immunogenicity profiles when compared directly to Orencia.
Currently, a pivotal Phase 3 study, known as AB-01-004, is actively underway. This advanced trial is focused on comparing the efficacy and safety of DRL_AB with that of Orencia. The outcomes of this study are anticipated to play a crucial role in the regulatory decision-making process, potentially paving the way for market approval.
This development underscores Dr Reddy's ongoing efforts to expand its portfolio in the biologics space, aiming to enhance treatment accessibility for patients grappling with chronic inflammatory conditions.
