CECMED, the Cuban Regulatory Agency for Medicines and Medical Devices, has gained valuable experience in registering biosimilars, with 15 approved products in the country. This experience has highlighted commonalities with international regulations. The agency’s insights into the biosimilar registration process and alignment with global standards contribute to the broader understanding of regulatory practices in the field.

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.

Contract Manufacturing Organisations (CMOs) and Contract Development and Manufacturing Organisations (CDMOs) are vital in the global pharmaceutical market, but are notably rare in Latin America, while Contract Research Organisations (CROs) are more common.Transitioning from small in-house projects and academic capabilities to a fully professional and validated scenario is a complex task. Competitiveness, encompassing costs of goods, timelines, success rates, and a global approach, remains a key challenge. Moreover, navigating the intellectual property landscape is crucial, as it impacts both the development of biosimilars and the capacity to offer related services. In Mexico and the rest of the region, they offer a promising way to bridge the gap between foreign investors and local infrastructure and demand.

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.

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.

With Mexico’s New Regulatory Certainty Strategy and other regulatory developments in the LatAm region, there are new considerations to explore. The importance of harmonising regulatory approaches with other agencies, the role of the public, private and social sectors, and compliance with ICH guidelines are among the factors that have been taken into account when preparing this new strategy. Its impact will play a crucial role in fostering the widespread adoption of biosimilars throughout Latin America.

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