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
John E. Feliciano Alfonso
Clinical Pharmacologist and Clinical Epidemiologist, University Professor
Giancarlo Videla Yarlequé
Senior Specialist in Clinical and Pharmaceutical Logistic Operations
Patricia Socualaya Sotomayor
Chief Officer at Biological Product Unit
Program at a Glance
Looking Back to Biosimilars in FDA
Beginning of the regulatory framework for Biosimilars in these agencies
Private Initiatives for Biosimilars Development
The advances that laboratories have made in Colombia
Challenges for innovation
What does it take to introduce innovative drugs in Latam
Proper communication between Companies and Healthcare Professionals
Recommendations for a healthy and clear communication
Biosimilars success stories
Experiences from companies in other countries that can help the Colombian industry
Communication of Regulatory Agencies in Latam
The requirements and suggestions from ANMAT and DIGEMID
What is expected to happen once the pandemie is over
Full programme in the PDF Agenda
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