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:









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

Program at a Glance

New Biosimilar Vision in Brazil, PDP Policy Update and Other Mechanisms for Production


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

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Previous Speaker Board

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


We are a vibrant science and technology company. Science is at the heart of everything we do, it drives the discoveries we make and the technologies we create. For more than 350 years, curiosity has been driving us to deliver excellence to patients and customers – and to imagine the future.


Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions.


Pall associates around the world are unified by a singular drive: to solve our customers’ biggest filtration, separation and purification challenges. And, in doing so, advance health, safety and environmentally responsible technologies. 

Our industry-leading technologies and solutions are at work in countless applications, safeguarding health, protecting critical operating assets, improving product quality, and minimizing emissions and waste. 

Our Life Sciences and Industrial teams bring focused expertise to a diverse range of customers across multiple industries, including biotechnology, pharmaceutical, medical, food and beverage, laboratory, microelectronics, aerospace, fuels, petrochemical, chemical, automotive and power generation .


Cytiva is a global provider of technologies and services that help advance and accelerate the development and production of therapeutic products. Promoting training, speed and efficiency for research and production workflows, allowing the delivery of innovative medicines to patients.



We develop alliances with pharmaceutical companies, using Terumo technology to develop, manufacture and supply solutions to injectable drug delivery challenges. We pride ourselves on offering a portfolio of products and services for the pharmaceutical industry. By anticipating trends and maintaining a constant dialogue, we provide a first class customer experience.


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.


With 60+ dedicated scientists and support personal, UDIBI is a third-party laboratory authorized by the Mexican Regulatory Agency (COFEPRIS) to conduct analytical services for the pharmaceutical and medical devices industries. We also provide consulting services on antibody engineering and development of antibody-based therapeutics. With the support from government and private investment we have developed a portfolio of biotherapeutics that includes a product in the market and several therapeutic antibodies in diverse phases of discovery, optimization and preclinical development. In response to COVID-19 pandemic, UDIBI developed and commercializes the only 100% Mexican diagnostic kit to detect anti-SARS-CoV-2 antibodies with approval by COFEPRIS for commercialization in Mexico.

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