Improved Regulation for Mexico’s Biotechnology Industry with Establishment of New Norm 

 enero 25, 2022

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On December 11, 2014, Mexican Official Norm NOM-257-SSA1-2014 was published in the Official Journal of the Federation (DOF), setting out the requirements for the evaluation, registration, clinical trial authorisation, and specifications for biotechnology medicines. These medicines make up the most innovative drugs for cancer, rheumatoid arthritis, diabetes, and other chronic and degenerative diseases, and account for 35% of all new drug approvals. The complex manufacturing processes for biopharmaceuticals, genetically engineered from living organisms, including bacteria, yeasts and animal cells grown in reactors under controlled conditions, make them mind-blowingly expensive and also challenging to replicate on a ‘generic’ level upon patent expiry. Nonetheless, with such huge prices, alternatives are essential for public access and the growth of Mexico’s biocomparable market is seen as key. As Francisco Kuri, New Developments Manager of Landsteiner Scientific, warned at the Biopharma 2014 event in Mexico City, an unaffordable and inaccessible medicine is a medicine that essentially does not exist. In Mexico to date, the market entry of biocomparables has already contributed to price reductions of up to 96% in the field. The approval of the Norm now goes some way to establishing an equal playing field for all biotechnology producers in the hope of allowing the industry to thrive.

The journey to develop the market in Mexico has been ongoing for some time. Article 222 bis of the General Health Law provided the definition and legal basis for biopharmaceuticals for the first time in Mexico in 2009. This established that only innovative and biocomparable biopharmaceuticals would be allowed in Mexico, and all biopharmaceuticals needed to comply with strict tests to demonstrate quality, safety, and efficacy. In October 2011 specific further requhttps://mexicosalud.com/wp-content/uploads/2015/01/Biocomparables-02_picnik.jpgirements for products’ quality, safety, and efficacy validation were established by virtue of the Regulations for Health Supplies (RIS). Subsequently, Mexican Official Norm NOM-177-SSA1-2013 was published in September 2013, setting out the tests and methods for drug interchangeability, including biocomparability studies as well as guidelines and requirements for third parties and research centers performing these studies. A period of uncertainty amongst the Mexican biotechonology community follwed this in which companies feared the withdrawal of their biogenerics from the market. The implementation of NOM-257-SSA1-2014 now clarifies the position futher and should therefore provide some relief.

The norm sets out the role of COFEPRIS and its New Molecules Committee and Biotechnology Products Evaluation Subcommittee in determining the necessary tests for biocomparables on a case-by-case basis. The quality assurance program that manufacturers must implement, including process validations, product and process auditing, and preventive and corrective actions reporting is also established. Furthermore the norm dictates that clinical trials authorization for biotechnology drugs will follow the same process as any other pharmaceutical. Pharmacovigilance must be conducted according to NOM-220-SSA1-2012 and biocomparability studies according to NOM-177-SSA1-2013. Reference drugs for biocomparability studies must be registered in Mexico and COFEPRIS will publish a list of authorized reference biopharmaceuticals drugs online.

Prior to the development of the regulatory framework for biosimilars in Mexico, local companies registered comparibles under the general generic category. Now that the regulation is approved and implemented, companies must comply with new and stricter requirements in order to demonstrate their biocomparability if they want to renew current registrations. Such measures should reduce the liklihood of disputes similar to that between Roche and Probiomed, which culminated in the withdrawal of Probiomed’s Rituximab biocomparable from the market. The withdrawal was ultimately not due to quality issues, but failure to meet compliance requirements. To address such scenarios, NOM-257-SSA1-2014 includes a transitory article allowing companies an extended timeframe to meet new requirements and present the necessary tests required by COFEPRIS. This will also create both need and opportunities for research centers and local laboratories in Mexico to provide services for the complete range of biocomparability studies.

Biocomparables undoutedly represent an area of increasing opportunity in Mexico over the coming decade. In an interview with Sandra Sanchez-Oldenhage, Director General of Probiomed, Sanchez again stressed the importance of biocomparables in meeting public health needs, with innovative biophamaceuticals representing such a strain on public budget. Beyond even accesiblity, on a broader level Sanchez believes that ultimately biocomparables will support futher R&D by allow for cost-saving alternatives to free up budget for reinvestment in further innovations. Mikel Arriola, head of COFEPRIS, has confirmed his commitment to establishing a complete, modern and transparent rule system for both local and multi-national manufacturers of biotechnolgy with the aim of placing Mexico at the forefront of the industry in the Latin American region. Former head of COFERPIS and industry expert, Augusto Bondani, explained to MHR that the new Norm is certainly on the right path for achieving a national policy for biotechnology. Looking to the road ahead, Bondani believes that further efforts by the government are essential and should include prioritizing new drug applications of biopharmaceuticals at COFEPRIS, opening the IMSS‪ to clinical trials and biocomparability studies, investing more funds through CONACYT, and providing fiscal incentives for biotechnology companies as done in Korea and India.


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