#China #Guangzhou #Bio-Thera #BAT2506 #Simponi

FDA Acceptance of BAT2506

Bio-Thera Solutions, Ltd, a biopharmaceutical company based in Guangzhou, has achieved a significant milestone with the acceptance of its Biologics License Application (BLA) for BAT2506 by the U.S. Food and Drug Administration (FDA). This proposed biosimilar is designed to replicate the effects of Simponi® (golimumab), a well-regarded drug used to treat various autoimmune disorders.

The FDA's goal date for review is set for May 16, 2026, as part of the Biosimilar User Fee Act (BsUFA). The BLA submission was made by Accord BioPharma, Bio-Thera’s commercialization partner in the United States, which will take on the role of marketing authorization holder if BAT2506 receives FDA approval.

Indications for BAT2506

The BLA includes requests for approval across all current presentations and indications for Simponi, which include:
1. Moderately to severely active rheumatoid arthritis (RA) in adults, often used alongside methotrexate.
2. Active psoriatic arthritis (PsA) in adults, either as a standalone treatment or in combination with methotrexate.
3. Active ankylosing spondylitis (AS) in adults.
4. Moderately to severely active ulcerative colitis (UC) for adults who are dependent on corticosteroids or who have not responded well to other treatments.

Bio-Thera is also requesting that BAT2506 be classified as interchangeable with Simponi, a vital feature that could enhance patient access to effective treatment options.

Research and Development Efforts

The BLA is supported by extensive data from a comprehensive analysis of biological similarities between BAT2506 and both U.S. and EU versions of Simponi. Bio-Thera conducted a thorough analytical characterization focusing on structural, physicochemical, and biological properties. Additionally, a randomized double-blind phase I study assessed pharmacokinetics, safety, and immunogenicity in healthy volunteers, comparing BAT2506 with Simponi products.

A multicenter, randomized phase III study further validated the efficacy and safety of BAT2506 against the EU Simponi in patients diagnosed with active psoriatic arthritis, demonstrating comparable results across all measures of performance. These collective evidence points to BAT2506 having similar efficacy, quality, and safety profiles to the reference product golimumab.

Company’s Commitment

Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions, expressed satisfaction over the FDA's acceptance of the BLA, remarking on how this development edges the company closer to providing high-quality, cost-effective treatment options for autoimmune patients across the United States. This marks the fourth BLA submission Bio-Thera has made to the FDA for a biosimilar, underscoring its ongoing commitment to this therapeutic segment.

About Bio-Thera Solutions

Bio-Thera Solutions is not only focused on developing biosimilars but also innovating new treatments designed to address unmet medical needs, including in fields such as oncology and autoimmune diseases. Since its inception, the company has made significant strides in bringing multiple therapeutic candidates to late-stage development, showcasing an unyielding dedication to improving healthcare.

With its evolving portfolio, which includes successful products deployed in China and extensive ongoing clinical trials, Bio-Thera is firmly positioned to make notable contributions to global health solutions.

More details about Bio-Thera Solutions' initiatives and its current pipeline can be found on their official website or through their social media channels.