In October 2024, China based Bio-Thera Solutions (Bio-Thera) and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Johnson & Johnson’s Stelara (ustekinumab).
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis [1].
Under the terms of the agreement, Bio-Thera will be responsible for development, manufacturing, and supply of BAT2206, and Richter will have exclusive rights to commercialize the product in the European Union, Switzerland, the UK, and selected other countries.
Bio-Thera filed for regulatory approval of BAT2206 with the European Medicines Agency on 1 July 2024.
In 2021, Bio-Thera entered a licensing and supply agreement with Pharmapark for BAT2206. Under this agreement, Russia’s Pharmapark has exclusive rights to distribute and market the drug, which holds the status of a local product in Russia and other Commonwealth of Independent States countries [2]. This agreement builds on a prior licensing and supply agreement between the two companies to market a golimumab biosimilar [3].
Bio-Thera has also out-licensed this biosimilar to Hikma Pharmaceuticals to commercialize the product in the US [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Ustekinumab biosimilars: new international biopharma agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/pharma-news/ustekinumab-biosimilars-new-international-biopharma-agreements
3. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/pharma-news/Bio-Thera-partners-with-Pharmapark-to-market-golimumab-biosimilar-in-Russia-and-other-CIS-countries
4. GaBI Online - Generics and Biosimilars Initiative. Licensing agreements signed for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/pharma-news/licensing-agreements-signed-for-ustekinumab-biosimilars
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