Bio-Thera Solutions Signs Exclusive License Deal with Intas for BAT2506 Biosimilar in the U.S.

Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America.

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.

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506. Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America. Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD.

“Accord BioPharma 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 USA.”

“Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy,” said Chrys Kokino, U.S. President of Accord. “We’re investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Bio-Thera’s global experience makes them an excellent partner.”