Accord BioPharma Strengthens Pipeline Through Exclusive U.S. Licensing Agreement with Bio-Thera for BAT2506, a Proposed Golimumab Biosimilar

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Feb 10, 2025, 08:30 ET

BAT2506, a tumor necrosis factor-alpha (TNF-alpha) blocker, is a Phase 3 biosimilar candidate to Simponi^® (golimumab)
Agreement will provide Accord BioPharma with future U.S. commercialization rights to BAT2506, while Bio-Thera will maintain responsibility for product development, manufacturing, and supply

RALEIGH, N.C., Feb. 10, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and critical care therapies, announced today that it has reached an exclusive commercialization and license agreement with Bio-Thera Solutions ("Bio-Thera") for BAT2506, a biosimilar candidate to Simponi^® (golimumab).

BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab, a human monoclonal antibody, inhibits the biological activity of tumor necrosis factor alpha (TNF-alpha). Originator product Simponi^® is approved in the U.S. for moderate to severe rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis and moderate to severely active UC, and carries a Boxed Warning for Serious Infection and Malignancy. In 2023 worldwide sales of Simponi^® (for subcutaneous injection) and Simponi Aria^® (for intravenous infusion) totaled approximately $3.2 billion, representing a compelling opportunity for Accord BioPharma to broaden patient access to biologics and build scale in immunology, a high-demand therapeutic area.

"Our U.S. portfolio of biosimilars continues to rapidly expand at multiple levels across the drug development and commercialization cycle," said Chrys Kokino, U.S. President of Accord. "In addition to developing and marketing our own biosimilar products, we're strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market as swiftly as possible."

"The U.S. biologics market is predicted to grow rapidly in the coming years. Biosimilars can play a transformative role in creating unique opportunities for stakeholders across the healthcare value chain," said Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals. "This agreement reaffirms our commitment to improving the patient experience."

"Accord is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in the USA."

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506, while Accord will have exclusive rights to commercialize the product in the U.S.

About Accord BioPharma
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.

About BAT2506
BAT2506 is a biosimilar candidate to Simponi^® (golimumab). Binding of golimumab to TNF-α 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.

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 four approved products: QLETLI^® and BETAGRIN^® (Bevifibatide Citrate Injection) in China, and TOFIDENCE/ BAT1806 and Avzivi^® / Pobevcy^® in the US, 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 ADCs. For more information, please visit www.bio-thera.com/en/.

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