

Biosimilars LatAm – Mexico 2024
The 2024 edition in Mexico aims to provide insights into local and international regulatory matters, explore biobetters and next-generation biologics, discuss the impact of biosimilar licenses on pharmaceutical innovation in Mexico, and delve into the evolving landscape of nearshoring and newshoring strategies in the industry.

Who will
you meet?
More than:
Participants
Companies
HCPs
Patients
Academy
Investors
Institutions
Associations
Service Providers
Government Agencies
Industry Executives from Latam
- Biosimilars
- Biobetters
- Biotechnology
- Biotherapeutics
- Analytical science
- Regulatory compliance
- Quality Control
- Clinical immunology
- Scientific Affairs
- Pharmacovigilance
- Research
- Regulatory
- Business Development
- Marketing
Speaker Board

Gloria Berrutti
Director of International Business Latam

Patrick Devlyn
President Healthcare Commission

José Avalos Rogel
General Director

Raman Wattamwar
CEO

Pedro Pablo Chavarría Juárez
Regulatory Affairs Director

Talita Ferreira
Consultant

Fernando Portugal
Director of Intellectual Property, Legal and International Affairs

Meenu Wadhwa
Section Leader, Cytokines & Growth Factors Section

Eduardo Perusquia García
Director of New Developments & Quality

Antonio Eduardo Sánchez García
VP of Public Policies for Devices

Oscar César Bustamante García
Regulatory Affairs Manager

Maria Yolanda Cervantes Apolinar
Senior Consultant and Expert in Vaccines

Vinicius Marçal
Business Development Manager

Haleh Hamedifar
Chairperson

Mauricio Barrón
Customer Application Specialist

Mario Novoa Belman
Sales & Application Specialist

Stephan Jarpa Cuadra
Director

Ximena Marcela Bonilla Forero
Research Leader Pharmaceutical Biotechnology Unit

Irma Garcia Morales
Regional Compliance Head Mexico & LATAM

Fernando Goicoechea Romero
General Manager LatAm

Rodrigo Ruíz Ramírez
Senior Manager Pharmacovigilance

Nestor Perez
COO and R&D Director

Oscar Raziel Gamiz Vargas
Sr. Marketing Manager Pharmaceutical Systems LATAM

Sonia Mayra Pérez Tapia
Executive Director

Jaime Uribe
Member of Biosimilars Committee

Fernando Fon
Director Medical and Regulatory Affairs

Jonathan Pablo Aceves Martinez
Global Regulatory Affairs Director, Regulatory Science
Program at a Glance
Biosimilar Regulatory Updates
In Mexico, the Federal Commission for the Protection against Sanitary Risks (Cofepris) has significantly improved access to biotechnological and biosimilar medicines by simplifying the approval process and accepting clinical data from other countries. By recognizing standards from the World Health Organization (WHO) and the Pan American Health Organization (PAHO), Cofepris has facilitated the evaluation of these products. These regulatory modifications not only accelerate the availability of biosimilars but also reduce costs, providing essential therapeutic options in areas such as oncology and autoimmune diseases, ultimately benefiting both patients and the healthcare system.
Invited: COFEPRIS
Biobetters and Next-Generation Biologics
The next generation of biologics, including biobetters, promises even more specific and effective treatments. This is crucial for addressing complex diseases such as cancer, autoimmune diseases, and rare diseases. Research and development in this field are constantly evolving. Scientists are working to optimize biobetters to achieve a balance between efficacy, safety, and accessibility.
Streamlining Biosimilar Approval: MHRA's Approach to Waiving Comparative Efficacy Testing
The Impact of Biosimilar Licenses on Pharmaceutical Innovation in Mexico
The regulatory strategy implemented by the Mexican government, through COFEPRIS, has created a competitive environment that not only reduces the costs of biological treatments but also encourages companies to invest in research and development of new therapies. However, these benefits have not quelled the debate over the impact of biosimilars on continuous innovation.
Benefits and Challenges of Regulatory Harmonization Efforts in Latin America
Nearshoring is Dead, Long Live Newshoring
The panel aims to explore the benefits and challenges of regulatory harmonization efforts in the biosimilar industry, focusing on how streamlined processes can facilitate drug manufacturing and market access. Designed for an audience of pharmaceutical industry executives, the discussion will highlight best practices and lessons learned from various regulatory environments, including insights from Asia. This global perspective will offer valuable takeaways for businesses looking to expand their reach beyond Mexico, emphasizing how international collaboration can drive innovation and improve access to affordable, high-quality biosimilars across different markets.
Full Programme in the PDF Agenda
Download Agenda

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