China-based Bio-Thera Solutions (SHA: 688177) has announced a licensing agreement with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group and a leading pharmaceutical company in the Middle East and North Africa (MENA) region. The agreement pertains to BAT2206, Bio-Thera’s biosimilar version of Roche’s (SWX: ROG) Stelara (Ustekinumab). Under the terms of the accord, Tabuk will obtain exclusive rights to manufacture, distribute, and market BAT2206 in Saudi Arabia, while Bio-Thera will handle the full development and commercial supply of the drug from its manufacturing facilities in Guangzhou, China. Financial details of the agreement were not disclosed.
Stelara’s Global Impact and Biosimilar Development
Stelara, the world’s first all-human “dual-targeted” interleukin 12 (IL-12) and interleukin 23 (IL-23) inhibitor, has received five indication approvals in the US, covering a range of conditions including ulcerative colitis, Crohn’s disease, active psoriatic arthritis, and psoriasis in addition to plaque psoriasis. Stelara was first approved in China in 2017. BAT1706, developed as a biosimilar in accordance with regulations in China, the US, and EU, is awaiting regulatory decisions in the latter two regions.
Global Commercialization Efforts for BAT2206
Bio-Thera has been proactive in global commercialization efforts for BAT2206. In June of the previous year, the company handed over commercial rights to Biomm S.A. for Brazil. This was followed by a similar agreement with Hungary-based Gedeon Richter Plc in October this year, covering the EU, UK, Switzerland, Australia, and some other European countries.-Fineline Info & Tech
