China-based Bio-Thera Solutions (SHA: 688177) has announced the addition of a third biosimilar to its existing license agreement with Costa Rican partner SteinCares, which was initially struck in March of this year. Under the revised accord, SteinCares will gain exclusive rights to distribute and market the new biosimilar in Brazil and across the Latin American (LatAm) region. Financial details of the agreement have not been disclosed.
Responsibilities and Regional Expertise
Bio-Thera will maintain responsibility for the research and development, manufacturing, and commercial supply of the biosimilar product. SteinCares, with its extensive experience and deep understanding of the Latin American healthcare system, will take the lead in commercializing the product with an optimal market strategy tailored to the region.
Regulatory Filings and Support
Bio-Thera will handle the regulatory filings with the FDA and EMA, which will support regulatory submissions in the LatAm region. SteinCares will manage the regulatory filings in Brazil and other Latin American countries, leveraging its regional expertise to expedite the process.
Original Deal and Expansion
The original deal granted SteinCares exclusive rights to distribute and market Bio-Thera’s biosimilars of Simponi (golimumab) and Nucala (mepolizumab) for Brazil and the entire LatAm region. This new addition to the partnership signifies a further expansion of both companies’ commitment to bringing affordable biosimilar options to patients in Latin America.-Fineline Info & Tech
