Bio-Thera Solutions (Bio-Thera) announced in March 2024 a licensing agreement with SteinCares to market two biosimilars in Brazil and the rest of the region.
Costa Rica-based SteinCares is a specialty healthcare company in Latin America, specializing in the commercialization and distribution of high-complexity pharmaceutical products, including innovative, biosimilar, and complex generic products.
China-based Bio-Thera Solutions is an innovative global biopharmaceutical company dedicated to researching and developing new therapies for the treatment of cancer, autoimmune diseases, cardiovascular, and ocular diseases, as well as biosimilars for existing branded biological products to treat a range of oncological and autoimmune diseases.
Under the licensing agreement, SteinCares will have exclusive rights to distribute and commercialise two Bio-Thera biosimilars in Brazil and the rest of the region. Bio-Thera will be responsible for the development of each biosimilar and for submitting the required documentation to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to support approvals in Latin America. It will also be responsible for the supply of the biosimilars from its production facilities in Guangzhou, China.
On 6 December 2023, the FDA approved Bio-Thera's bevacizumab biosimilar (BAT1706), named Avzivi (bevacizumab-tnjn), which is globally marketed by Sandoz [1]. On 29 September 2023, the FDA also approved Tofidence (tocilizumab-bavi) as the first biosimilar of Actemra (tocilizumab) marking the first approval of this kind for tocilizumab biosimilars in the US [2]. Tofidence was developed as a result of a partnership between Biogen and Bio-Thera. In January 2023, Bio-Thera announced that China's NMPA approved BAT1806, a biosimilar of Actemra (tocilizumab), making it the first biosimilar of tocilizumab to receive approval worldwide [3].
The alliance that SteinCares and Bio-Thera have formed to commercialize biosimilars in Latin America aims to offer accessible and safe treatments to patients. According to the CEOs of both companies, this partnership strengthens SteinCares' position as a leader in the regional biosimilars market and expands product availability in Brazil and Latin America.
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LATIN AMERICAN FORUM
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Avzivi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/news/fda-approves-bevacizumab-biosimilar-avzivi
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence
3. GaBI Online - Generics and Biosimilars Initiative. China approves tocilizumab copy biological BAT1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/news/china-approves-tocilizumab-copy-biological-bat1806
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