Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, announced that the company has partnered with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group, for BAT2206, its ustekinumab biosimilar, under which Tabuk will have exclusive rights to manufacture, distribute and market the drug in Saudi Arabia.

BAT2206 is a proposed biosimilar to Jansen's Stelara. Bio-Thera has filed for regulatory approval of BAT2206 with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).

This partnership will leverage Tabuk's strong local presence, sales and marketing capabilities in Saudi Arabia. Under this agreement Tabuk Pharmaceuticals will hold the marketing authorisation and will be responsible to manufacture, register, import, and promote BAT2206 in Saudi Arabia.  Bio-Thera will be responsible for full development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China.

Commenting on the development, Dr. Shengfeng Li, CEO of Bio-Thera said, “Bio-Thera is pleased to establish a partnership with Tabuk to commercialise our ustekinumab biosimilar program in Saudi Arabia. Tabuk is a leading pharmaceutical company in the MENA region and is a great partner to ensure patients in Saudi Arabia have the best access to BAT2206.”

Ismail Shehada, CEO of Tabuk Pharmaceuticals remarked, “We are excited to announce our partnership with Bio-Thera that will enable us to deliver unique and specialized health solutions aimed at enhancing the well-being of people in Saudi Arabia. We are confident that this partnership supports our efforts to manufacture and localise biosimilar products in the region and strengthen our market leading position in line with our strategy. This also stands as a commitment from our side to support the 2030 vision of Saudi Arabia through localising biopharmaceutical products in the Kingdom.”