Regulatory Certainty Strategy for Biosimilar Drugs in Mexico - Uhthoff

Regulatory Certainty Strategy for Biosimilar Drugs in Mexico

Mexico has been continuously facing the new challenges related to the growing biotechnology industry. Mexican authorities have recognized that the current regulation does not generate the ideal conditions to allow the effective entry (from the clinical phase to obtaining marketing authorizations) of new innovative treatments, biosimilars or interchangeable generics.

Since November 2021, Mexico was accepted as a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), considered a priority strategy for the Federal Commission for the Protection against Health Risks in Mexico (COFEPRIS) allowing the homologation of regulation, surveillance, and technical evaluation parameters, and being one of the first steps for the setup of the regulatory certainty strategy for biosimilar. In this strategy, published on February 09, 2024, an essential role is played by the creation of units with specialized members (academic, government, health care, private and social sector), councils and committees for the improvement of the general process of biosimilar drugs in Mexico, integrated by experts in different areas, considering a continuous evaluation of the same, and establishing an initial 4-year project that covers the whole life cycle of the pharmaceutical product.

This project contemplates the implementation of short- and medium-term strategies that cover the stages of development, manufacturing, evaluation, authorization, distribution, and dispensation of biotechnological products.

COFEPRIS considers several essential points for this strategy, among which the following stand out:

1) Trade measures: i) Clarification on the application and scope of the Bolar Clause. Regarding pharmaceutical products covered by a patent, the United States and Canada legislation, the Federal Law for the Protection of Intellectual Property and the Free Trade Agreement between Mexico, the United States and Canada do not limit their use to a specific period prior to the expiration of the patent; however, the Healthcare Supplies Regulation (RIS) establishes a specific period of time to start the development of biosimilar drugs in the country (3 years). By the last quarter of 2025, COFEPRIS will make the necessary amendments to Articles 167 Bis and 177 Bis2 of the RIS to eliminate the time established by the Bolar Clause. ii) Modification to the Linkage mechanism and criteria for data protection. COFEPRIS proposes: a) to guarantee compliance with  international commitments of Mexico regarding data protection; b) implement more effective mechanisms for appeals and requests for clarification by companies engaged in pharmaceutical innovation when there are patents in force; c) facilitate access to the necessary processes for biosimilar drug manufacturers, within the legal framework, to begin the clinical phases in the development of their products, the first steps will be presented in the third quarter of 2024.

2) Cross-cutting actions: specialization and operational consolidation: (i) establish the Good Regulatory Practices Committee (BPR) (early 2024) for regulatory issues, quality and safety criteria, comparability, interchangeability, and ensuring accelerated approval procedures, among others; (ii) Create the Unit Specialized in Biosimilar Biotechnological Drugs (UEBio) (second quarter 2024) for reviewing evaluation, manufacturing and marketing of biocomparable drugs; iii) Create the Pharmaceutical Development Committee for Biosimilar Biotechnology Drugs (CODEBio) (second half of 2024), to evaluate whether the evidence presented by a biosimilar is comparable to the reference drug; iv) Facilitate the exchange of technical and scientific information between Mexico and other countries, improving the approval process for new drugs and promoting international collaboration.

3) Actions for the development phase of biosimilar and innovative biotechnology drugs: i) Define standards for conducting non-clinical trials (last quarter of 2025); ii) Improve the ecosystem for conducting biocomparability studies for the recognition of bioequivalence and biocomparability studies of the WHO guidelines; iii) Allow biosimilars to be compared with biotechnology drugs from abroad, eliminating the mandatory requirement to conduct studies in Mexican population. COFEPRIS will update the RIS and will carry out a comprehensive review of NOM-177-SSA1-2013 (demonstrating interchangeable drugs), in the last quarter of 2025. Expand the supply of Authorized Third Parties to perform biocomparability studies, ideally by the end of 2027; iv) continuous diagnosis to identify molecules of interest for the development of the most demanded and high-priority biosimilar biotechnological drugs whose patent is about to expire, by the last two months of 2025.

4) Actions for the manufacturing phase of biosimilar and innovative biotechnological drugs: (i) Regulatory update for Good Manufacturing Practices, modification of the related standard NOM-164-SSA1-2015, to include the section on biopharmaceuticals, eliminating them from the standard NOM-059-SSA1-2015 (first half of 2026); (ii) Restructuring of the New Molecules Committee seeking to optimize evaluation time and reactivate the Biotechnology Product Evaluation Subcommittee as of the second quarter of 2025; (iii) Homologation of evaluation criteria. Ensure exhaustive pharmacovigilance with general evaluation criteria and methodologies, expected by the beginning of 2025.

5) Distribution and dispensing: i) Improvements in distribution capacities: continuous training plan for distributors, transport, maintenance, and points of sale in good storage and distribution practices, last quarter of 2025.

Accordingly, COFEPRIS has established a joint agenda with different involved sectors trying to promote the production of biocomparable drugs within a fist stage of 4 years, generating important benefits to ensure IP protection when rights are In Force and on the other hand facilitating manufacture of biosimilars when protection lapses; additionally, economic development is an important target of the strategy, considering the growing demand for these promising therapeutic inputs.


Luis Fernando Granados Castro


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