

Biosimilars LatAm – Brazil 2023
The Forum provides in-depth regional analysis and information regarding commercialization strategies, regulation, good manufacturing and distribution practices, international market trends and more.
With a particular focus on providing the insight about the clinical practice and prescription of these drugs in the country, seeking for a greater access to biological treatments for patients in Brazil.
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
Program at a Glance
New Biosimilar Vision in Brazil, PDP Policy Update and Other Mechanisms for Production
ANVISA
Butantan - Sandoz: 2 New Biosimilars for Brazil. Reference Study
Reference Study
Biosimilar’s Real World Data
One great opportunity in Brazil are the PDP’s, the partnerships have to be mutually benefcial for the company (the technology holder) and the receptor company and the government.
CDMO Usability in Other Mechanisms for Production in Brazil
Interchangeability in Brazil. Data and Analysis
HCPs, Patients and Industry assesment of different molecules
Regulatory Agencies: New LatAm Landscape
Full Programme in the PDF Agenda
Download Agenda

Previous Speaker Board

Mariana Duarte de Cerqueira
Biotech Specialist

Alma Aidé Fernández Herrera
Pharmacovigilance Manager

Jorge Revilla
Medical Director

Maripaz Márquez Quiroz
Researcher

Bianca Schiavetti
Gastroenterologist

Albert Kim
Vice President, Commercial Strategy Team Leader

Ana Carolina Ferreira Cardoso
Scientific Relationship Coordinator

Manish Kumar Singh
Senior General Manager

David Honba
Head of Business Development

Marcelo Holanda
Head of Latam

Meiruze Freitas
Director

Prasad S. Deshpande
Senior Vice President & Global Head – Procurement, Supply Chain Management, Contract Manufacturing and Central Engineering

Martin Cruz
Executive Director

Laura Arce
Country Safety Lead for Central America and the Caribbean

Jose Antonio Maza Larrea
Director of the Pharmacovigilance section

Diego Rodríguez Baquero
Consultant, ex Brand, Launch and Project Manager

Cinthya Galicia
President / Country Safety Lead

Alecio Pimenta
Product Manager for Downstream

Daniel Freire
Regional Medical Director - LatAm

Monique Samaan
Senior Biotechnology R&D Scientist

Mauricio Ede-Filho
Chief Medical & Scientific Officer

Mariana Peixoto
President Sociedade Mineira de Reumatologia

Andrea Padovani
Head of the Pharmacological Clinical Evaluation Service of the Directorate of Evaluation and Control of Biological Products and Radiopharmaceuticals

Rodrigo Oliveira
Field Application Specialist, Healthcare

Kattia Riaño
Regulatory Affairs Manager

Gloria Giraldo
Senior Scientific Evaluator

Tore K. Kvien
Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway
Professor em/Senior Research Advisor

Julie Marechal-Jamil
Biosimilars Committee member & European Biosimilar medicines group

Dorthe Bartels
Senior Strategic Advisor, Negotiator and Head of the Biosimilar task force

Gustavo Mendes Lima Santos
ICH MC Member, General Manager of Medicines and Biological Products

Brian Godman
Sefako Makgatho Health Sciences University, South Africa
Professor

Natália Sousa Freitas Queiroz
Gastroenterology Sciences Postgraduate Program Professor

Edilson Uiechi
Institutional Affairs & Business Development Manager

Luciana Rahal
Independent Medical Affairs Professional

Marcos Roman Calgaro
Commercial Director LATAM, Bioproduction

Tiago Rocca
Strategic Partnerships and Business Development Manager

Shahin Kauser
Leading Senior Scientific Assessor

Daniel Morales
Epidemiologist and Academic GP

Elkiane Macedo Rama
Health Regulation Expert

Roberto Frontini
Pharmacovigilance Risk Assessment Committee (PRAC) alternate member
Program in 2022
Latest News on Regulatory Processes
For Brazil and ANVISA specifcally, regulatory convergence is a key point and a major value when looking forward to the effective resolution of the biosimilar challenges.
Greater Access to Safe and Effective Life-saving Medications
The main barriers for biosimilars uptake can vary depending on the stakeholder perspective. The main challenges are those related to education regarding biosimilars conceptualization and switching, therefore Biosimilar’s education should be stimulated and incorporated in the curriculum of all medical, nursing and pharmacy schools.
Tendering Procedures: Healthy Competition and Public Health
One great opportunity in Brazil are the PDP’s, the partnerships have to be mutually benefcial for the company (the technology holder) and the receptor company and the government.
Biosimilars Interchangeability
Interchangeability designation enables auto-substitution at the pharmacy level. The interchangeable product will have the same clinical result as the reference product.
Biosimilars Market Innovation: from Developing a Mindset for Global Competitiveness to Business Strategies
When it comes to biosimilars, we can innovate not only in the essence of the product but also in the essence of the business strategy.
PDP’s Success Stories
Samsung Bioepis and Bionovis partnerships is one of the best PDP cases. Since 2019, no delay in process of technology transfer, strong partnership with local partners, and the 1st Korean pharmaceutical company in 2019 to supply biosimilars through PDP. Samsung’s goal is providing biosimilars to enhance patient access to treatments in Brazil.
Protecting Patients: Minimization and Communication of the Risk of Adverse Reactions Focused on the Clinical Practice
Regulatory authorities and pharmacovigilance systems in Latin America and the Caribbean, and in general around the world, seek to be more proactive than reactive in communications and seek harmonization.
Good Distribution Practices: Stakeholders Perspective
Medication management during its manufacture, storage, distribution and prescription has a direct impact on patient safety.
GVP Case Study
Investing in education on health policies can help to minimize the Nocebo effect.
How Do Quality Considerations Impact Clinical Immunogenicity?
Sterility within Production Processes
Clinical Focus on Pharmacovigilance Systems
The clinical pharmacovigilance approach aims to promote the rational use of medication by implementing pharmaceutical attention services.
Case Study: European Market Dynamics
Biosimilars offer a way forward to improve the care of patients with proven similar effectiveness and safety between originators and biosimilars, e.g. NORSWITCH study in Norway.

Sponsors in 2022
Photo Gallery from Previous Events
