Bio-Thera Solutions (Bio-Thera) has partnered with Tabuk Pharmaceutical Manufacturing (Tabuk) to exclusively manufacture, distribute, and market BAT2206, a biosimilar to Stelara (ustekinumab), in Saudi Arabia. Simultaneously, Bio-Thera expanded its collaboration with SteinCares, granting exclusive rights to distribute an additional biosimilar in Latin America, reinforcing its global biosimilar strategy.
Bio-Thera, a China-based biopharmaceutical company, announced a partnership with Tabuk on 24 December 2024. The collaboration centers on Bio-Thera’s BAT2206, a proposed ustekinumab biosimilar to Janssen/J&J’s Stelara, granting Tabuk exclusive rights to manufacture, distribute, and market the drug in Saudi Arabia.
Bio-Thera has submitted regulatory approval of BAT2206 to several major agencies, including the China National Medical Products Administration, the European Medicines Agency on 1 July 2024 [1], and the US Food and Drug Administration (FDA) on 24 July 2024.
As part of the agreement, Tabuk – a leading pharmaceutical player in the Middle East and North Africa (MENA) region and a wholly-owned subsidiary of Astra Industrial Group – will hold the marketing authorization for BAT2206 in Saudi Arabia. The company will oversee manufacturing, registration, importation, and promotion of the product within the country. Meanwhile, Bio-Thera will manage the development and commercial supply of BAT2206 from its facilities in Guangzhou, China.
This partnership with Tabuk aligns with Bio-Thera's strategy to expand its biosimilar offerings across global markets. For instance, on 16 December 2024, the company announced progress in its collaboration with Costa-Rica-based SteinCares in Latin American, introducing a third biosimilar to the region. Earlier, in March 2024, Bio-Thera signed a licensing agreement with SteinCares to market two biosimilars. The updated agreement grants SteinCares exclusive rights to distribute and market an additional Bio-Thera biosimilar in Brazil and across the LATAM region [2].
Bio-Thera has entered into several strategic agreements to expand its global presence and facilitate the launch of its biosimilars. In October 2024, Bio-Thera partnered with Hungary’s Gedeon Richter, securing an exclusive commercialization and license agreement for BAT2206 in Europe [1]. Previously, in July 2020, the company signed a licensing agreement with Russia-based Pharmapark for its proposed golimumab biosimilar, BAT2506, covering Russia and other Commonwealth of Independent States [3].
Additionally, Bio-Thera achieved significant regulatory milestones with its biosimilars, tocilizumab (Tofidence) and bevacizumab (Avzivi). Both products received FDA approval in late 2023 and subsequently gained European Union approval in 2024 [4-6].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from:
www.gabionline.net/pharma-news/bio-thera-and-gedeon-richter-partner-to-commercialize-stelara-biosimilar-bat2206
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and SteinCares sign agreement to market two biosimilars in LATAM [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from: www.gabionline.net/pharma-news/bio-thera-and-steincares-sign-agreement-to-market-two-biosimilars-in-latam
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 2025 Feb 18]. 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. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Avzivi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from: www.gabionline.net/biosimilars/news/fda-approves-bevacizumab-biosimilar-avzivi
6. GaBI Online - Generics and Biosimilars Initiative. EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from: www.gabionline.net/biosimilars/news/ec-approvals-of-four-biosimilars-tofidence-wezenla-avzivi-and-steqeyma
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