Accord BioPharma, Inc., the US specialty division of Intas Pharmaceuticals, Ltd., has signed an exclusive commercialization and license agreement with Bio-Thera Solutions 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 US 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 USD 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 US portfolio of biosimilars continues to rapidly expand at multiple levels across the drug development and commercialization cycle. 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," said Chrys Kokino, US President of Accord.

"The US 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. This agreement reaffirms our commitment to improving the patient experience," said Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals.

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

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 US.