Licensing agreements signed for ustekinumab biosimilars

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Bio-Thera Solutions have signed an exclusive commercialization and licensing agreement with Hikma Pharmaceuticals for the ustekinumab (Stelara) biosimilar BAT2206, similar to an agreement reached between Meiji Seika Pharma, Dong-A ST and Intas Pharmaceuticals.


On 27 August 2021, China’s Bio-Thera Solutions (Bio-Thera) and Jordan’s Hikma Pharmaceuticals (Hikma) announced a commercialization and licensing agreement for BAT2206, a proposed biosimilar to ustekinumab (Stelara) that is currently in phase III trials [1]. Ustekinumab is a monoclonal antibody treatment for a number of inflammatory conditions including inflammatory bowel disease (IBD), plaque psoriasis and psoriatic arthritis.

Under the agreement, which relates to the US, Bio-Thera will have responsibility for development, manufacturing and supply of BAT2206, while Hikma will have exclusive rights to commercialize the product. The agreement also gives Hikma first right to negotiate to commercialize the product in Europe.

Dr Shengfeng Li, Founder and CEO of Bio-Thera Solutions, said: ‘Partnering with Hikma to commercialize BAT2206 […] further validates the high quality of the work performed at Bio-Thera. We are proud to expand our network of partners to include another great company like Hikma’.

Siggi Olafsson, CEO of Hikma, added: ‘Our established commercial presence in the US market and Bio-Thera’s strong technical capabilities for the development and manufacturing of biological products are highly complementary and we are excited by the potential this partnership offers’.

Meanwhile, Japan’s Meiji Seika Pharma (Meiji) and South Korea’s Dong-A ST have signed an exclusive licensing deal with India-based generics maker Intas Pharmaceuticals (Intas) for global rights to their ustekinumab biosimilar, DMB-3115. Meiji has recently announced positive phase I results for the biosimilar [2].

Under the terms of the agreement, Meiji and Dong-A ST will develop and manufacture DMB-3115 and supply the product, while Intas has exclusive licensing rights to commercialize DMB-3115 worldwide (excluding some countries in Asia, including Japan and Korea).

Vice Chairman of Intas, Binish Chudgar, said: ‘We are truly excited by this partnership, which brings together the development expertise of Meiji and Dong-A ST with the extensive commercial reach of Intas’.

Accord Healthcare, a subsidiary of Intas, will be responsible for acquisition and marketing in Europe and the US.

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1. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Meiji’s ustekinumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from:

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