Accord BioPharma Inc., the U.S. specialty division of Intas Pharmaceuticals Ltd., has reached an exclusive commercialization and license agreement with Bio-Thera Solutions for BAT2506, a biosimilar candidate to Simponi (golimumab).

Golimumab, a human monoclonal antibody, inhibits the biological activity of tumor necrosis factor alpha (TNF-alpha). The 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.

“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.”

“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 the development, manufacturing, and supply of BAT2506, while Accord will have exclusive rights to commercialize the product in the U.S. 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.

Other biosimilars in Bio-Thera’s portfolio include Tofidence, a biosimilar of Actemra, and Avzivi, a biosimilar of Avastin.