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Biologics and Biosimilars Regulations and Registration in Mexico (COFEPRIS)

Updated: Apr 21

Mexico is the second-largest drug market in Latin America, after Brazil.

With a compound annual growth rate (CAGR) of 38.7%, the Mexican biosimilars market has seen a growth from roughly $123.1 million in 2013 to roughly $631.5 million in 2019.

Biologics and Biosimilars Regulations and Registration in Mexico (COFEPRIS)

This article outlines the Biologics and Biosimilar Regulations and Registration process in Mexico (Cofepris)

Biologics: Biologics are complex molecules derived from living organisms and are used for various medical purposes, including the treatment of diseases like cancer, autoimmune disorders, and more. In Mexico, biologics are regulated by the Federal Commission for Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios or COFEPRIS). COFEPRIS is responsible for approving, regulating, and overseeing the manufacturing, importation, distribution, and use of biologics to ensure their safety, efficacy, and quality.

Biosimilars: Biosimilars are biological products that are highly similar to an already approved biologic reference product, with no clinically meaningful differences in terms of safety and efficacy. In Mexico, the approval and regulation of biosimilars also fall under the purview of COFEPRIS. Biosimilars must undergo a rigorous assessment process to demonstrate their comparability to the reference biologic, including comprehensive analytical, preclinical, and clinical studies. Biosimilars are considered "biocomparables" under Article 222 Bis of the Health Law since they must be comparable to reference items in terms of quality, safety, and efficacy.

Official Mexican guidelines for biosimilars are detailed under NORM NOM-257-SSA1-2014, NORM NOM-177-SSA1-2-13 and NORM NOM-220-SSA1-2016

Patentability: Mexico allows for the patenting of biologic drugs. If the specific product, among other things, satisfies the patentability conditions, then it may be possible to protect biosimilar medicines under IP rights.

Pre-registration requirements:

  1. Preclinical Development: Before initiating clinical trials, the manufacturer of a biologic or biosimilar typically conducts extensive preclinical studies to assess the product's safety, quality, and potential efficacy. This phase includes laboratory testing and animal studies.

  2. Clinical Trials: Clinical trials are conducted to gather data on the safety, efficacy, and quality of the biologic or biosimilar in humans. Clinical trials are conducted in several phases, starting with Phase 1 trials involving a small number of healthy volunteers and progressing to Phase 2 and Phase 3 trials involving larger patient populations. The design and conduct of these trials must adhere to international standards and guidelines.

  3. Comparative Studies for Biosimilars: For biosimilars, a key component of the regulatory process is demonstrating comparability to a reference biologic. Comparative studies, including analytical, pharmacokinetic, pharmacodynamic, and clinical studies, are conducted to establish similarity in terms of safety and efficacy between the biosimilar and the reference product.

Required Documents:

  1. Dossier Cover Letter: A cover letter that outlines the purpose of the submission and provides a brief overview of the contents of the regulatory submission.

  2. Quality Overall Summary (QOS) or Quality Module: This section includes detailed information about the manufacturing process, quality control, and quality assurance procedures for the biologic or biosimilar.

  3. Nonclinical Study Reports: Documentation of preclinical studies conducted to assess the product's safety, including pharmacology and toxicology studies.

  4. Clinical Study Reports: Comprehensive reports on clinical trials conducted to evaluate the safety, efficacy, and immunogenicity of the biologic or biosimilar.

  5. Comparability Studies (for Biosimilars): Detailed information and data from analytical, pharmacokinetic, pharmacodynamic, and clinical studies comparing the biosimilar to the reference biologic.

  6. Product Characterization: Detailed information about the structural and functional characteristics of the biologic or biosimilar, including information about the active substance, impurities, and product variants.

  7. Manufacturing Process Description: A detailed description of the manufacturing process, including information about the facilities, equipment, production steps, and controls.

  8. Control of Starting Materials: Documentation about the quality control and testing of starting materials used in the manufacturing process.

  9. Container Closure System and Stability Studies: Information about the packaging materials and design, as well as data from stability studies that demonstrate the product's shelf-life and storage conditions.

  10. Labeling and Packaging Information: Details about the proposed labeling, packaging, and instructions for use of the biologic or biosimilar.

  11. Pharmacovigilance Plan: A plan outlining how the manufacturer will monitor and report adverse events and safety information once the product is on the market.

  12. Environmental Risk Assessment (if applicable): Documentation assessing potential environmental risks associated with the manufacturing and disposal of the product.

  13. Data on Reference Product (for Biosimilars): Information about the reference biologic, including its manufacturing process and clinical data.

  14. Risk Management Plan: Details about how potential risks associated with the product will be managed and minimized.

Registration Pathway:

  • Data Submission: The manufacturer compiles all relevant preclinical and clinical data, including data from comparative studies for biosimilars, and prepares a comprehensive regulatory submission dossier for COFEPRIS.

  • Review Process: COFEPRIS reviews the submitted dossier to assess the safety, efficacy, and quality of the biologic or biosimilar. This review involves a thorough evaluation of the data, including the results of preclinical studies, clinical trials, and comparative studies for biosimilars.

  • Approval Decision: Based on the review, COFEPRIS makes a decision regarding the approval of the biologic or biosimilar. If the product meets all regulatory requirements and is deemed safe and effective, it can receive marketing authorization for use in Mexico.

  • Timelines: For biologics and biocomparables, the approval window is 180 calendar days. In actuality, these timelines might vary.

  • Fees: Review of manufacturing approval application costs around US$3,000, while Government fees for analyzing marketing authorization applications are around US$8,600 for new molecules/biologics and US$4,800 for generics/biocomparables.

Fastracking the approvals: There is a provision for products that are not approved in Mexico to be fast-tracked under Bioequivalence agreements for products approved in the USA, Canada, EU, Switzerland, and Australia

Post-Marketing Surveillance

  • Pharmacovigilance System: Manufacturers of biologics and biosimilars are required to establish and maintain a robust pharmacovigilance system. This system is designed to monitor and collect information about any adverse events, side effects, or safety concerns related to the use of their products in real-world settings.

  • Reporting Requirements: Manufacturers are obligated to promptly report any adverse events or safety concerns to COFEPRIS. This includes serious adverse events, unexpected side effects, or any other new safety information that becomes available. COFEPRIS relies on this information to assess the ongoing safety profile of biologics and biosimilars.

  • Healthcare Professionals and Patient Reporting: In addition to manufacturer reporting, healthcare professionals and patients are encouraged to report any adverse events or safety concerns they observe or experience while using biologics or biosimilars. These reports contribute to a comprehensive understanding of the product's safety profile.

  • Signal Detection and Evaluation: COFEPRIS analyzes the collected data to identify potential signals of new or previously unrecognized safety issues. If necessary, COFEPRIS may request additional information from the manufacturer, conduct further investigations, or take regulatory actions to address safety concerns.

  • Risk Management: Based on the findings of post-marketing surveillance, COFEPRIS may require manufacturers to implement risk minimization strategies, update product labeling with new safety information, or take other measures to ensure that the benefits of the product continue to outweigh its risks.

  • Periodic Safety Update Reports (PSURs): Manufacturers are typically required to submit Periodic Safety Update Reports to COFEPRIS at regular intervals. These reports provide an overview of the safety data collected during a specific time period and may include updates on the benefit-risk assessment of the product.

  • International Collaboration: COFEPRIS may collaborate with international regulatory agencies and organizations to share safety data and stay informed about global safety trends and concerns related to biologics and biosimilars.



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