Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced a licensing agreement with STADA Arzneimittel AG for BAT2506, a biosimilar version of Johnson & Johnson’s (J&J) Simponi (golimumab). Under this agreement, STADA will secure exclusive commercialization rights for the product across the European Union (EU), the United Kingdom (UK), Switzerland, and other European markets.
Bio-Thera will handle the research and development, manufacturing, and commercial supply of BAT2506, while STADA is set to make an upfront payment of USD 10 million. Additionally, STADA has committed to milestone payments totaling USD 147.5 million and will pay double-digit sales commissions.
Golimumab, a human tumor necrosis factor-α (TNF-α) monoclonal antibody (mAb), received market approval in China in 2018 for the treatment of active ankylosing spondylitis and moderate to severe active rheumatoid arthritis (RA) in patients with an inadequate response to antirheumatic drugs, in combination with methotrexate. BAT2506 is a biosimilar developed in accordance with guidelines in China, the US, and EU and has completed global Phase III clinical trials.- Flcube.com
