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.
Sources:
https://www.gob.mx/cms/uploads/attachment/file/891381/Estrat_Cert_Regul_Biosimilares_b.pdf
Luis Fernando Granados Castro
fgranados@uhthoff.com.mx
