In February of this year, Cofepris published its Regulatory Certainty Strategy focused on biosimilars with which they want to establish and make transparent the regulatory framework that will be applied in Mexico (which they intend to be aligned with international standards) for manufacturing, evaluation, and authorization of these products.
It is important to note that biosimilars are biotechnological drug products, which are compared against a reference innovative biotechnological drug product. The authorization of biosimilar biotechnological drug products allows for therapeutic alternatives with the same efficacy (as the reference innovator) at a lower cost. The critical point in these drug products is to evaluate the molecular comparability (through specific studies), in order to confirm their similarity with the reference drug product, and at this point the implementation of an accurate and transparent regulatory framework is directed so that the quality, safety and efficacy of biosimilar drug products can be ensured.
Currently, the applicable regulatory framework is unclear, and there is a tendency to over-regulate. With the regulatory certainty strategic plan, what they want to achieve is:
– Encourage the development and manufacturing of biosimilar biotechnological products in Mexico.
– Establish a robust regulatory framework that is aligned with international standards in order to provide regulatory certainty.
– Promote the capacity of the industry through specific regulatory support strategies in the research and production phases of the drug product.
In order to achieve these three aspects, Cofepris establishes a period of 4 years to develop and implement the regulatory framework that allows achieving the objectives established in the regulatory certainty strategy, beginning in 2024.
Among some of the relevant points of this strategy are the following:
– The creation of the Specialized Unit in Biosimilar Biotechnological Drug products, in the second quarter of 2024. This will be an interdisciplinary group that would focus on address in an specialized and efficient way, the evaluation manufacturing, and marketing of biosimilar drug products.
– The creation of the Pharmaceutical Development Committee for Biosimilar and Biotechnological Drug products, starting in the second quarter of 2024. This Committee will promote the generation of guidelines and recommendations that consider aspects of product development and will be responsible for fully evaluating the evidence presented by a biosimilar to determine if it is biocomparable to the corresponding reference drug product and the opinion of this committee will be considered to obtain the Marketing approval of a biosimilar.
– Comprehensive update of the regulatory framework for the handling and recognition of biocomparability studies, through the adoption of WHO guidelines, elimination of the requirement to perform clinical studies in Mexican population, improve recognition mechanisms for biocomparability studies carried out in countries with health authorities recognized by the WHO.
– Update of the Health Supplies Regulation within 2024.
– Comprehensive review of NOM-177-SSA1-2013 in the last quarter of 2025.
– Develop and establish a guideline with clear and differentiated criteria for modifications in the conditions of the Marketing Approval of biosimilars, categorizing them as major, moderate and minor. That is planned for last quarter of 2025.
– Modification of NOM-164-SSA1-2015 Good Manufacturing Practices for Drugs (API) to include a specific section for biological drugs (API) (first half of 2026)
– Update of NOM-059-SSA1-2015 in order to eliminate the section on biological drugs (API) and limit the field of application exclusively to pharmaceutical finished drug products (first half of 2026).
– Restructure the New Molecules Committee, with the purpose to reactivate the Biotechnological Products Evaluation Subcommittee (second quarter of 2025).
It sounds like a comprehensive strategy to promote access to biosimilar and biotechnological drugs in Mexico. Collaboration with chambers, associations, and professional colleges could indeed amplify efforts and streamline implementation. Building synergies can lead to more effective outcomes and wider availability of these important medical alternatives to all Mexican patients.
