Bio-Thera Solutions (SHA: 688177), a Chinese biopharmaceutical company, has entered into a licensing agreement with SteinCares, a Costa Rican healthcare provider. Under the terms of the deal, SteinCares will obtain exclusive rights to distribute and market two of Bio-Thera’s biosimilars across Brazil and the Latin America (LatAm) region. The financial details and the specific biosimilars included in the agreement have not been disclosed.
Bio-Thera will handle the development and regulatory submissions for the biosimilars with both the US FDA and the European Medicines Agency (EMA), which will subsequently support the regulatory process in the LatAm region. The company will also supply the biosimilars from its manufacturing facilities in China. SteinCares will take the lead on the go-to-market strategy, utilizing its established presence and sales and marketing expertise within the region.
Bio-Thera has recently gained US FDA approval for its biosimilar versions of Avastin (bevacizumab) in December 2023 and Actemra/RoActemra (tocilizumab) in October 2023. The company also markets a biosimilar version of Humira (adalimumab) in China, showcasing its capabilities in developing and commercializing biosimilar products.- Flcube.com
