Regulatory certainty for Biosimilars in Mexico.

The Ministry of Health and COFEPRIS released a document proposing a “Regulatory Certainty Strategy for the Pharmaceutical Sector: Biosimilars”.

The purpose of this strategy is to promote the development of biocomparable drugs by establishing an institutional and regulatory framework in line with international standards, which would be implemented according to the strategy in the period 2024-2026, in order to promote the industry’s capacity in all phases of research and production of these products in Mexico, mainly based on the following axes:

  • Establishment of a BPR Committee for regulatory adjustments, change management activities, accompanying mechanisms and biosimilars evaluation.
  • Establishment of the Biosimilars Specialized Unit (UEBio).
  • Creation of CODEBio that will provide binding recommendations for obtaining a biosimilar marketing authorization.
  • Harmonization of national regulation to ICH standards, the PIC/S, as well as the adoption of WHO guidelines, among other memberships in the field.
  • Follow up on the certification as Regulatory Agency level IV of maturity in the regulation of biological products, through the WHO Global Benchmarking Tool.
  • Implementation of safety guidelines through the issuance of Mexican standards.
  • Comprehensive updating of the regulatory framework in relation to bioequivalence and biocomparability studies.
  • Review of NOM-177-SSA1-2013 (Establishing the tests and procedures for bioequivalence and biocomparability studies) with the guidelines of the WHO’s “Guide for the evaluation of biosimilars”.
  • Outline a regulatory framework for Risk Analysis (RA).
  • Expand the list of Authorized Third Parties (AT) for biocomparability studies.
  • Technical and operational strengthening of the Social Security Mexican Institute (IMSS), for clinical research, in accordance with ICH.
  • Regulatory update for Good Manufacturing Practices and promotion of recognition of GMPs issued by Mexico.
  • Inclusion of new quality criteria.
  • Creation of a regulatory accompaniment figure.
  • Restructuring of the New Molecules Committee, reactivation of the Subcommittee for the Evaluation of Biotechnological Products, along with CODEBio.
  • COFEPRIS assumes the commitment to standardize criteria in the evaluation of finished products with a training plan aimed at the UEBio.
  • Intensification of pharmacovigilance work.
  • Running a training program on good storage and distribution practices.
  • Implementation of a regulatory strengthening and support program for BIRMEX.
  • Establish standardized criteria for dispensing medicines in hospitals and pharmacies for both sectors.
  • Issuance of reference guidelines for cross-change as a complementary strategy to strengthen Good Dispensing Practices for medicines in hospitals.
  • Creation of a group of experts to determine the interchangeability criteria.
  • Elimination of the temporalities of the Roche-Bolar exception (i.e. 3 years, 8 years).
  • In relation to the patent linkage system and clinical data protection, COFEPRIS proposes:
  • I) Clarifying the limits and applications of legal instruments.
  • II) Implementing more effective mechanisms for companies dedicated to pharmaceutical innovation.
  • III) Facilitating access to the necessary processes, within the legal framework, to begin the clinical phases in the development of biosimilars.
  • Creation of a National Pharmaceutical Development Council to encourage investment in scientific projects and academic offerings in biotechnology for pharmaceutical purposes.

OLIVARES will continue to analyze the legal and practical impact and effects of this strategy and will closely monitor the development and implementation of each of these proposals which will require amendments to our regulatory framework in order to provide timely advice to our clients.


Alejandro Luna F.


Alejandro Luna joined OLIVARES in 1996 and being made partner in 2005, he has been instrumental to the firm’s IP Litigation, Regulatory, and Administrative Litigation practices. He co-chairs the Life Sciences & Pharmaceutical Law industry group and coordinates the Litigation Department.

Gustavo Alcocer


Gustavo Alcocer manages the Corporate and Commercial Law Group at OLIVARES, advising domestic and foreign businesses and the owners of those businesses on Mexican and cross-border corporate and commercial transactions.

Armando Arenas


Armando Arenas joined OLIVARES in 2000 and became a partner in January 2017. He has experience working on a range of IP matters, including consulting and litigation on trademark, patent, unfair competition, trade dress protection, and misleading advertising cases before the Mexican Institute of Industrial Property (IMPI), Federal Court of Tax and Administrative Affairs (FCTA), Federal Circuit Courts (FCC) and the Supreme Court of Justice (SCJ) Regulatory Affairs and Public Acquisitions.



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