Biosimilars LatAm – Europe 2024

This forum serves as a space to expand upon Latin America’s opportunities for European biosimilar manufacturers, providing regulatory insight for the region and exploring diverse mediums for partnerships, such as PDPs, contract manufacturing, and nearshoring.

The event will feature presentations and participation from renowned industry experts and regulatory agency representatives, who will share their extensive knowledge, experience, and insights within the biotechnology field.

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

Speaker Board 

Program at a Glance

Biosimilars in Spain: Financing and Economic Impact

The financing and economic impact of biosimilars in Spain are critical considerations within the country’s healthcare system. Biosimilars offer potential cost savings compared to their reference biologics, thus reducing financial strain on healthcare budgets. Additionally, increased biosimilar uptake can stimulate market competition, leading to lower prices and improved access to innovative treatments for patients.

Strategies to Enhance Collaboration between European Biosimilar Manufacturers and Latin American Regulatory Authorities

Enhancing collaboration between European biosimilar manufacturers and Latin American regulatory authorities is crucial for advancing healthcare accessibility. Strategies include fostering dialogue platforms, sharing best practices, and harmonizing regulatory frameworks. By promoting mutual understanding and alignment, these efforts facilitate efficient market entry for biosimilars, ensuring patients across Latin America benefit from safe and affordable treatment options.

Clinical Development Requirements and Guidelines for Biosimilars in Latin America

Latin America’s clinical development requirements for biosimilars can vary significantly across countries, in contrast with the Europe. Brazil, Mexico, and Argentina have established national regulatory guidelines, while Chile and Colombia rely on WHO guidelines. Despite differences, all countries emphasize robust comparative clinical studies to demonstrate biosimilarity. Harmonization efforts aim to streamline processes, ensuring efficient and consistent evaluation of biosimilar safety and efficacy across the region.

PDPs: The Success of Brazilian Partnerships for Productive Development

Brazilian Partnerships for Productive Development (PDPs) exemplify successful collaborations between local public and private sectors, but may also offer a blueprint for potential European biosimilar manufacturers. By leveraging government incentives and industry expertise, PDPs foster local production of essential medicines and vaccines, benefiting both parties. This win-win partnership enhances healthcare accessibility while presenting opportunities for European biosimilar manufacturers to expand into new markets.

Emerging Technologies Addressing the Current Essential Medicine Access Gap

Recent therapeutic innovations in biologics and biosimilars have increased access to life-saving medicines. However, CHO-based production remains costly and limited, affecting availability for 90% of the global population. Bio-Sourcing technology, using gene-editing in transgenic goats’ milk, offers a scalable, low-cost alternative. This disruptive platform can produce affordable biotherapeutics like insulin and monoclonal antibodies, transforming global healthcare.

The Landscape for Biosimilar, Innovation, and Innovator Access in Peru

In Peru, navigating the landscape of biosimilars poses unique challenges, balancing innovation with access to original biologics. While biosimilar adoption is on the rise, concerns persist regarding regulatory clarity and market competition. Innovator access remains crucial for advancing healthcare, requiring strategic policies to ensure affordability and availability without compromising quality and safety standards in this dynamic pharmaceutical landscape. A robust regulatory framework is key to improving access to healthcare in Peru.

How Mexico's Regulatory Certainty Strategy Facilitates Market Entry of European Producers in Mexico

In Mexico, COFEPRIS is currently undertaking a strategic initiative to provide regulatory certainty to pharmaceutical companies, enabling them to introduce medical innovations and drive productive development in the Mexican market. The 2022−2030 agenda aims to foster competitiveness, industrial and commercial growth, and ensure access to safe and high-quality healthcare products. The implementation of this strategy focuses on harmonising regulatory approaches with other agencies, involving the public, private and social sectors, and compliance with ICH guidelines, among other factors. This strategy enhances investor confidence and facilitates timely market access, positioning Mexico as an attractive destination for European producers looking to expand their presence in the region.

Institutional Initiatives for Local Production of Biologics in Colombia

Colombia faces a significant gap in local biosimilar production, highlighting the country’s dependency on imported biologic drugs. However, promising initiatives are emerging. The District Institute of Science, Biotechnology and Innovation in Health (IDCBIS), among other organizations, is spearheading efforts to establish local manufacturing capabilities. This strategic move aims to enhance accessibility to crucial biologic treatments, potentially reshaping Colombia’s pharmaceutical landscape.

The History and Challenges of Regulatory Harmonization Efforts in Latin America

 The pursuit of regulatory harmonization in Latin America faces historical hurdles, rooted in diverse legal frameworks and differing standards across countries. Efforts by organizations like the Pan American Health Organization (PAHO) strive to streamline regulations, enhancing access to safe and effective medical products. Despite progress, challenges persist, including disparities in resources, political will, and enforcement mechanisms, hindering comprehensive harmonization.

Market Access Challenges and Opportunities for Biosimilars in Latin America

Latin America faces both challenges and opportunities in biosimilar market access. Brazil, Mexico, and Argentina lead in regulatory frameworks but encounter hurdles like pricing and reimbursement policies. Colombia’s tender-based system drives market competition, while Chile prioritizes cost-effectiveness evaluations. Despite challenges, these countries offer substantial opportunities for biosimilar penetration, driven by growing demand for affordable biologic therapies and advancing regulatory landscapes.

Full Programme in the PDF Agenda

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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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