IHS Global Insight Perspective | |
Significance | Article 222 introduces a new regulatory framework for biotech and biosimilar drugs in Mexico, delineating the official definition of these products and the requirements to register and market this type of drug. This resolution follows a series of delays and increasing discussions over the positive and negative consequences of a stronger legal outline for commercialised biotech products in the country. |
Implications | The implementation of a regulatory framework for biotech and biosimilar drugs is a ground-breaking move which provides Mexico with a positive environment to develop and commercialise this type of product. These changes will provide increased opportunities for national and multinational companies, as well as the increasing number of patients undergoing treatment for chronic diseases such as diabetes and cancer. |
Outlook | Article 222 provides a stronger platform for this sector's development, which coupled with the growing profitability of this market and increasing investments from governmental institutions and pharmaceutical companies, the biotech industry is expected to be one of Mexico's top growing areas in the following years. |
Article 222 has been added to the general health law in Mexico, where it introduces a regulatory framework for biotech and biosimilar drugs commercialised in the country. This resolution follows a series of delays and increasing discussions over the positive and negative consequences of a stronger regulatory framework for these products (see Mexico: 3 March 2009: Biotech Drugs Regulation on Hold by Cofepris).
Article 222 outlines the definition of such products, as well as the requirements to register and commercialise them in the market. According to this new regulation, biotech drugs are defined as products developed through biotechnological molecular processes, characterised by a therapeutic function and identified through their pharmacological attributes. Innovative biotech products are considered as the outline for biosimilar drug development. Biosimilar drugs are labelled as "biocomparables".
Article 222 will come into effect 90 days after its publication in the official federal newspaper on 11 June. The health secretariat will have 180 days to issue the required legal regulations to implement these changes.
Sanitary Registrations, Labelling and Name Designation
Sanitary registration processes for biotech drugs will be based upon the fulfilment of pre-clinical and clinical trials that ensure the quality, safety and efficacy of these products. Once the registration processes are completed, pharmacovigilance (PV) systems are expected to help assess and prevent possible adverse effects in patients using these drugs. In the case of biosimilar medications, companies are required to present clinical and/or in vitro studies that support the product's quality and efficacy compared to the branded version of the medication.
Medications failing to fulfil these requirements will be evaluated by the Comite de Moleculas Nuevas (New Molecules Committee) on a case-by-case basis. The committee has been implemented to expedite the registration process and reduce the waiting period before a product enters the market. The sub-committee of biotech product evaluation will also collaborate in these processes. This sub-committee will be introduced in the following 90 days, with the participation of different health institutions such as the National Institute of Genomic Medicine and several representatives from the health authority and the general council of health regulations.
Labels for biotech and biosimilar drugs are expected to include information such as the name of the manufacturer, the place of origin, the packing location and the importing company when applicable. The designation of the biotech products should include their international non-proprietary name (INN).
Outlook and Implications
The introduction of a regulatory framework for biotech drugs in Mexico is a fundamental step to further develop this industry and ensure the safety of consumers within the country. It represents a ground-breaking step for Mexico towards becoming a worldwide leader within this sector and serves as a role model for many countries, particularly within the region.
Article 222 is expected to benefit national as well as multinational firms interested in the biotech sector in Mexico. Looking into the national industry, Mexican major Silanes is likely to experience a significant boost in the market and enhance the company's opportunity to compete with multinational rivals (see Mexico: 3 June 2009: Mexican Silanes' New Strategy of Growth Points to European Markets and the Biotech Sector). This is especially true if Silanes becomes interested in expanding into the Latin American region, where with the exception of Brazil, countries do not have any requirements for national clinical tests to commercialise biotech products. Mexican Probiomed Biotechnology Complex, the largest Latin American biotech plant, is also expected to experience significant benefits from the new regulatory framework.
The government is expected to become one of the main clients of these companies, in particular if they offer less costly biosimilar products. This is a direct consequence of the growing numbers of Mexican patients suffering from chronic diseases, which are commonly treated with biotech drugs. Growth hormone, insulin products and treatments for cancer and multiple sclerosis (MS) are expected to be emphasised. Moreover, the Mexican Council for Science and Technology is expected to increase its funding role within the sector and benefit national companies interested in entering this market.
Multinational companies such as Roche (Switzerland), Eli Lilly (U.S.), Wyeth (U.S.) and Novartis (Switzerland), which are interested in developing biotech products, are expected to take advantage of Mexico's stronger regulatory environment. The elimination of local manufacturing requirements for biotech products expected to come into effect on 5 August will also increase multinational opportunities within this sector and boost Mexico's attractiveness to international players (see Mexico: 9 February 2009: Second Phase of Manufacturing Requirements’ Elimination Comes Into Effect in Mexico).