Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi®

GUANGZHOU, China, July 16, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi^® (golimumab).  The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 16^th May 2026.

The BLA was submitted by Bio-Thera's US commercialization partner Accord BioPharma, who will be the MA holder if BAT2506 is approved by FDA.  Accord BioPharma filed the BLA with FDA on 16^th May 2025.  The BLA requests approval for all approved presentations and all currently approved indications for Simponi, including 1) moderately to severely active rheumatoid arthritis (RA) in adults, used with methotrexate, 2) active psoriatic arthritis (PsA) in adults, used alone or with methotrexate, 3) active ankylosing spondylitis (AS) in adults and 4) moderately to severely active ulcerative colitis (UC) in adults who depend on corticosteroids or haven't responded well to or tolerated other treatments. The BLA also requests BAT2506 be declared interchangeable with Simponi.

Bio-Thera and Intas entered into a license and commercialization agreement for BAT2506 in February 2025. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Accord BioPharma, the U.S. specialty division of Intas is responsible for the commercialization of BAT2506 in the United States.

"The FDA's acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing autoimmune patients in the USA with a high-quality, low-cost treatment option," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera is committed to developing, manufacturing and commercializing biosimilars in the US and this marks the fourth FDA BLA that Bio-Thera has filed for a biosimilar."

The BLA submission is based on a comprehensive analytical, non-clinical, and clinical data package submitted to the FDA. Extensive analytical characterization between BAT2506 and US and EU Simponi^® was conducted on structural, physicochemical, and biological properties to support bio-similarity of BAT2506. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT2506^® with both the US and EU Simponi^® in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared BAT2506 with EU Simponi^® for efficacy, safety, and immunogenicity in patients with active psoriatic arthritis. The totality of the evidence demonstrated that BAT2506 has similar efficacy, safety, immunogenicity, and quality as the reference product golimumab.

About BAT2506
BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- a), a pro-inflammatory molecule. Binding of golimumab to TNF-a results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers.  The reference medicine golimumab has been approved in the United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI^® (adalimumab) and BETAGRIN^® (bevifibatide citrate) Injection in China, STARJEMZA^® in the US, and BAT1806/TOFIDENCE^TM (tocilizumab) and AVZIVI^® (bevacizumab-tnjn) in the US, a/k/a POBEVCY^® in EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).

About Intas Pharmaceuticals
Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas' biosimilars are manufactured at Intas Pharmaceuticals' state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at www.intaspharma.com. 

About Accord BioPharma, Inc
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com.

Bio-Thera Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to BAT2506, or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise.

Contact
Bert E. Thomas IV
Phone: +1.410.627.1734
Email: [email protected]

SOURCE Bio-Thera Solutions, Ltd