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
- Biosimilars
- Biobetters
- Biotechnology
- Biotherapeutics
- Analytical science
- Regulatory compliance
- Quality Control
- Clinical immunology
- Scientific Affairs
- Pharmacovigilance
- Research
- Regulatory
- Business Development
- Marketing
Speaker Board
Mayra Guadalupe Quiñonez Alvarado
Head of Bioanalytical Control
Vanessa Schiavo
Regulatory Affairs Manager
Silvia Giaffone
Sr. Manager, Global Safety - Pharmacovigilance lead for Brazil Hub
Rocio Parra
Global Strategy Director
Srinivas Komala
Country Manager Brazil
Pedro Pablo Chavarría Juárez
Regulatory Affairs Director
Rafael Costa
Strategy and Business Executive Director
Tonatiuh Cortes Esquivel
Sr Strategic Project Manager
Rodrigo Ruíz Ramírez
Senior Manager Pharmacovigilance
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
Download Agenda
Photo Gallery from Previous Events