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.
Who will
you meet?
More than:
Participants
Companies
HCPs
Patients
Academy
Investors
Institutions
Associations
Service Providers
Government Agencies
Industry Executives from Latam
From these areas:
- Biosimilars
- Biobetters
- Biotechnology
- Biotherapeutics
- Analytical science
- Regulatory compliance
- Quality Control
- Clinical immunology
- Scientific Affairs
- Pharmacovigilance
- Research
- Regulatory
- Business Development
- Marketing
Speaker Board
Monique Samaan
Cristalia, Brazil
Senior Biotechnology R&D Scientist
Senior Biotechnology R&D Scientist
Mauricio Ede-Filho
Sandoz, Canada
Chief Medical & Scientific Officer
Chief Medical & Scientific Officer
Mariana Peixoto
Sociedade Mineira de Reumatologia, Brazil
President Sociedade Mineira de Reumatologia
President Sociedade Mineira de Reumatologia
Andrea Padovani
ANMAT, Argentina
Head of the Pharmacological Clinical Evaluation Service of the Directorate of Evaluation and Control of Biological Products and Radiopharmaceuticals
Head of the Pharmacological Clinical Evaluation Service of the Directorate of Evaluation and Control of Biological Products and Radiopharmaceuticals
Rodrigo Oliveira
bioMérieux, Brazil
Field Application Specialist, Healthcare
Field Application Specialist, Healthcare
Kattia Riaño
Sandoz, Colombia
Regulatory Affairs Manager
Regulatory Affairs Manager
Gloria Giraldo
Health Canada, Canada
Senior Scientific Evaluator
Senior Scientific Evaluator
Tore K. Kvien
Faculty of Medicine, University of Oslo, Norway
Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway
Professor em/Senior Research Advisor
Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway
Professor em/Senior Research Advisor
Julie Marechal-Jamil
IGBA, Belgium
Biosimilars Committee member & European Biosimilar medicines group
Biosimilars Committee member & European Biosimilar medicines group
Dorthe Bartels
Amgros, Denmark
Senior Strategic Advisor, Negotiator and Head of the Biosimilar task force
Senior Strategic Advisor, Negotiator and Head of the Biosimilar task force
Gustavo Mendes Lima Santos
Instituto Butantan, Brazil
Director of Regulatory, Quality and Clinical Trials
Director of Regulatory, Quality and Clinical Trials
Brian Godman
University of Strathclyde, UK
Sefako Makgatho Health Sciences University, South Africa
Professor
Sefako Makgatho Health Sciences University, South Africa
Professor
Natália Sousa Freitas Queiroz
University of Sao Paulo School of Medicine, Brazil
Gastroenterology Sciences Postgraduate Program Professor
Gastroenterology Sciences Postgraduate Program Professor
Edilson Uiechi
Bionovis, Brazil
Institutional Affairs & Business Development Manager
Institutional Affairs & Business Development Manager
Luciana Rahal
Brazil
Independent Medical Affairs Professional
Independent Medical Affairs Professional
Marcos Roman Calgaro
Thermo Fisher Scientific, Brazil
LatAm Bioproduction Director
LatAm Bioproduction Director
Tiago Rocca
Butantan Institute, Brazil
Strategic Partnerships and Business Development Manager
Strategic Partnerships and Business Development Manager
Shahin Kauser
MHRA, United Kingdom
Leading Senior Scientific Assessor
Leading Senior Scientific Assessor
Daniel Morales
University of Dundee, United Kingdom
Epidemiologist and Academic GP
Epidemiologist and Academic GP
Elkiane Macedo Rama
ANVISA, Brazil
Health Regulation Expert
Health Regulation Expert
Roberto Frontini
EMA, Germany
Pharmacovigilance Risk Assessment Committee (PRAC) alternate member
Pharmacovigilance Risk Assessment Committee (PRAC) alternate member
Fernando Carmona
Cytiva, Argentina
Upstream and Cell Culture Sales Specialist
Upstream and Cell Culture Sales Specialist
Nicolas Estrada
Merck, Mexico
Single-use Customer Applications
Single-use Customer Applications
Cristina Ausin
FDA, USA
Scientific Reviewer
Scientific Reviewer
Thiago Mares Guia
Bionovis, Brazil
Executive Vice President
Executive Vice President
Philippe Lauwers
Terumo, Belgium
Technology Development Director
Technology Development Director
Program at a Glance
Market Access Best Practices
A Conversation about Overcoming Barriers on Market Entry and Uptake of Biosimilars to Enrich the Brazilian Experience.
Biosimilars and their Impact on Latin America's Growing Pharmaceutical Market
Due to the loss of patent exclusivity of several biological pharmaceuticals in upcoming years. Market share, development and production of vaccines
Pharmacovigilance Challenges for Biosimilars
Procedures and Best Practices to Accurately Track and Trace Biologics, Including Biosimilars and Their Reference Products, Detect Safety Signals and Promoting Effective Tools Among Prescribers.
Biosimilars Regulatory Licensing Framework
Biosimilars Regulatory Licensing Framework, International Review.
Success Stories Surrounding Biosimilars
Stories about Biosimilars Helping to Conserve Resources and Enhance Access to Biologics.
Originator and Biosimilar Market Dynamics
Upcoming Considerations for Biosimilars in Brazil
What’s the future of biosimilars after the pandemic is under control
Full programme in the PDF Agenda
Download Agenda