Biosimilars LatAm – Global 2026

Connecting Latin America’s opportunities with the world.

This edition is where global biosimilar leaders meet Latin America’s momentum. The forum connects C-level executives, visionaries, innovators, and regulators shaping the future of biotherapeutics — from access and policy to innovation and collaboration.

This flagship event builds on over ten years of impactful editions across the region, offering a unique space to exchange insights, forge partnerships, and drive the next chapter of biosimilars worldwide.

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

Program at a Glance

Regulatory Innovation & Global Convergence in Biosimilars

Explore how international cooperation and regulatory innovation can accelerate biosimilar approvals while ensuring globally aligned standards for quality, safety, and efficacy. The session will highlight successful experiences from agencies such as EMA, FDA, ANVISA, and COFEPRIS, as well as convergence initiatives led by PAHO and WHO.

Access, Equity & Affordability: Making Biosimilars Reach All Patients

Analyze strategies to improve equitable access to biosimilars across Latin America and globally. The discussion will focus on reimbursement models, public procurement mechanisms, incentive policies, and educational programs that build trust and drive sustainable biosimilar adoption.

Nearshoring, Investment & Strengthening Regional Biomanufacturing

Assess how production relocation and public–private partnerships can enhance pharmaceutical self-sufficiency and reduce import dependence. The panel will explore investment opportunities, government incentives, and technological challenges in establishing regional biomanufacturing hubs.

Sustainable Biosimilar Manufacturing: Environmental and Economic Impact

Promote the integration of sustainability into biosimilar manufacturing practices. The session will discuss strategies to minimize carbon footprint, optimize energy and water use, and align production models with ESG (Environmental, Social, Governance) frameworks that create long-term value.

Strengthening Latin America's Local Biosimilar Ecosystem

Analyze how alliances with foreign entities facilitate entry into new markets.This panel will explore how latin america can develop a sustainable biosimilars ecosystem by combining local innovation, international regulatory compliance (EMA/FDA), and strategic global partnerships.

Global Regulatory Alignment and Reliance Models for Biosimilars

Discuss strategies for strengthening local manufacturing capabilities, encouraging investment, and promoting international competitiveness. The session will cover public–private partnerships, technology transfer, and incentives for expanding biosimilar production from Latin America to global markets.

Innovation in R&D and Streamlined Regulatory Pathways

Discuss how research & development innovation and regulatory pathway optimization can accelerate biosimilar entry to market without compromising safety or efficacy. The aim is to identify regulatory flexibilities, adaptive clinical designs, and risk-based approaches to reduce delays.

Strategic Alliances & Global Expansion for Biosimilars

Explore how strategic alliances—between local manufacturers and global actors, public-private partnerships, licensing agreements, and cross-border collaborations—can enable Latin American biosimilar developers to scale globally. Focus on mechanisms, success stories, and barriers to international expansion.

Cybersecurity in Connected Medical Devices: Protecting Innovation

Explore strategies to safeguard connected medical devices against cybersecurity risks while ensuring patient safety and fostering innovation.

Regulatory & Market Challenges: Harmonization, Compliance and Global Standards

Address the main regulatory and market barriers for biosimilars in achieving international alignment with EMA, FDA, and WHO standards. The session will focus on improving regulatory predictability, enhancing transparency, adopting global best practices, and accelerating approval timelines while ensuring product quality and safety.

Full Programme in the PDF Agenda

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