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Advancing Biosimilars in Latin America: A Comprehensive Analysis of Regulatory Frameworks, Market Trends, and Future Perspectives

Mike Rizo, Juan Velazquez

Pharmcare Services




Introduction: With the struggle to find cost-effective therapeutic options, there has been increased market interest for biosimilars in the Latin American region. This paper presents an in-depth exploration of the biosimilar landscape in Latin America. Methods: Key recommendations from the “Recommendations for the regulation of biosimilars and their implementation in Latin America,” as published in the Generics and Biosimilars Initiative Journal in 2014, were synthesized and integrated into insights from various reputable sources. Results: A nuanced perspective on the regulatory landscapes, market dynamics, and the challenges and opportunities that define the biosimilar ecosystem in Latin America. Discussion: There are persistent challenges in the Latin America, including physician and patient acceptance, pharmacovigilance, and the need for continuous education. However, there are several potential opportunities for growth and development within the region. Conclusion: Latin American countries would benefit from banding together to form an organization that allows all to contribute and benefit from relationships formed naturally by common geography, language, and goals


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