The discussion related to these products has changed dramatically from those had in previous years; in the past, the industry was discussing the regulatory framework and how the different regulatory agencies, from Mexico to Argentina, would regulate these new therapeutic options. Now, after the maturity of the laws and the construction of different regulatory pathways for biosimilars in most of the countries, the discussion has moved on to the different challenges that the industry, whether local or foreign, faces in commercializing biosimilars.
In most of the countries, governments are promoting the introduction of the biosimilars, due in part to the constraints they face in paying for high-cost innovative biologics, in addition to controlling healthcare spending linked with the increasing prevalence of diseases like cancer, diabetes, and other chronic conditions.
in the coming years, we will see a dynamic market with many players moving between countries with different regulatory frameworks and health system compositions, all trying to survive deep price reductions while demonstrating added value through the development of more real-world evidence or benefits in product improvements. At the same time, we will see these players increasing patient access to medicines. In the end, patients will benefit from these market dynamics with the introduction of therapeutic options that can help to overcome the access disparities that our region currently has.
Industry Executives from Latam
- Analytical science
- Regulatory compliance
- Quality Control
- Clinical immunology
- Scientific Affairs
- Business Development
Head of the Pharmacological Clinical Evaluation Service of the Directorate of Evaluation and Control of Biological Products and Radiopharmaceuticals
Mexico, Colombia, Brazil and Argentina - Regulatory update
Advantages of Stimulating Local Production to Allow Self-Sustainability
Key Aspects to Enter the Latam Market for Biosimilars
How to Reach a Level for International Competitiveness
Why is Colombia the Next Stop for Biosimilar’s Production?
Brazil, Advances in Pharmacovigilance
Full programme in the PDF Agenda
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