Mexico is making proactive and systematic strides towards shaping the future of the pharmaceutical industry within the country and ambitiously across the entire region.
The “Estrategia de Certidumbre Regulatoria 2022-2030” (Regulatory Certainty Strategy) was recently presented by COFEPRIS. This well-defined strategy ultimately aims to enhance access to therapies in Latin America. This strategy recognizes the need for local market growth and emphasizes the importance of fostering interconnections within the region, across the continent, and globally.
The Mexican edition of the forum highlights investment as a crucial catalyst for promising growth, elucidates the investment sector’s interests and concerns, and provides proactive measures to navigate the upcoming COFEPRIS-defined scenario effectively.
Industry Executives from Latam
- Analytical science
- Regulatory compliance
- Quality Control
- Clinical immunology
- Scientific Affairs
- Business Development
Previous Speaker Board
Program at a Glance
The Benefits of the New Regulatory Certainty Strategy
COFEPRIS is 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.
Streamlining Biosimilar Approval: MHRA's Approach to Waiving Comparative Efficacy Testing
In 2021, the UK’s MHRA eliminated the need for comparative efficacy trials in most cases, provided there is a scientific rationale. The MHRA justifies this by stating that the efficacy and safety of a biologic can generally be understood through its biological activity. This change allows biosimilar manufacturers to launch products in the UK faster and at a lower cost compared to other regions.
Experiences in Nearshoring and Potential Partnerships with Local Producers
“Nearshoring” in Mexico is gaining momentum as multinational companies seek to relocate their business and manufacturing closer to home. The effects of the COVID-19 pandemic and global supply chain disruptions have prompted a reevaluation of sourcing options, making Mexico an attractive destination. Foreign investment in low-cost pharmaceutical manufacturing is on the rise, with many companies considering nearshoring to Mexico more advantageous than reshoring to the US, though emerging markets like India are also showing increasing investment. The presence of international pharma companies in Mexico is significant, driven by government regulations and a growing focus on the biosimilars market and innovative drug R&D, with a considerable interest from international investors.
How Market Access Differs Significantly from Region to Region: LatAm, USA, Europe and Asia
The 2014 World Health Assembly resolution urges WHO Member States to enhance access to biotherapeutics, ensuring their quality, safety, and efficacy. Despite progress made, including improved availability of biotherapeutics and biosimilars, significant access gaps persist, in some regions more than others. Beyond guideline updates, factors that can hinder market accessibility are similarity, comparability, substitution, pricing and reimbursement.
Investment in Biosimilars in Mexico: Incentives, Expectations and Concerns
Mexico possesses abundant resources and great potential for investment, but lags behind when it comes to regulatory clarity, suitable partnerships, and international awareness of its local infrastructure and academia. To attract investors, it is crucial to raise international awareness, incentivise them to explore the advantages of the Mexican market and, in turn, to understand their concerns, interests, and expectations of investors considering Mexico as a viable market for biosimilar initiatives.
Technology for Processes and Single-Use Technologies for Cell and Gene Therapy
As cell and gene therapies transition from research and development to commercialisation, manufacturers face new challenges. The need to expedite the market entry for these transformative therapies introduces a high risk of implementing inefficient workflow processes. Single-use solutions offer productive strategies for scaling up these processes effectively, while simultaneously reducing risks and costs, and the technology can minimise obstacles associated with a batch by replacing it with a new pre-validated system. By adopting these innovative methods for in-process sampling, manufacturers can significantly enhance workflow efficiency and effectiveness.
Regulatory Perspective of Europe and the US: Plans for Mexican Market Approval
With Mexico’s New Regulatory Certainty Strategy and other regulatory developments in the LatAm region, the regulatory bodies from Europe and the US have formulated their individual plans and strategies for the Latin American biosimilars market. As the importance of harmonising regulatory approaches grows, these influential agencies are dedicated to enhancing accessibility and ensuring the safety of biosimilars in the region. Exploring potential collaborations, harmonisation efforts, and best practices will play a crucial role in fostering the widespread adoption of biosimilars throughout Latin America.
Full Programme in the PDF Agenda
Thermo Fisher Scientific is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivitin their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
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.
As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.
Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.
We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.
Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.
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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.