Augusto Bondani
Former Commissioner of Sanitary Authorization (CAS)
COFEPRIS
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Defining the Right National Policy for Biotechnology Drugs

Sat, 09/05/2015 - 13:04

Q: What was the process followed to create the regulatory framework for biosimilars?

A: It was believed that biosimilar medicines could not have the same safety and efficacy as innovative medications because characterizing and comparing proteins was rather difficult. However, with technological advances in characterization and more adequate designs of pre-clinical and clinical trials, it is possible for biosimilar medications to be compared with innovators in terms of safety and efficacy. The first significant development in terms of regulating biotechnology drugs was the 2007 Interinstitutional Forum at the Mexican Chamber of Deputies hosted by President of the Health Commission. After this modifications to the law were issued, and during my time as Commissioner we collaborated further with CANIFARMA. These meetings lead to the creation of the Regulation of Biotechnology Medicines. This represented a big challenge for biosimilars that had been approved without the adequate pre-clinical and clinical studies to prove efficacy and safety. However, at that time, stopping their sale would have represented a serious problem for the health sector in economic terms. Therefore, it was necessary to reach agreements with CANIFARMA, resulting in certain norms and guidelines to temporarily solve the problem. It is expected that all biosimilar products will have the adequate studies to demonstrate safety and efficacy for use by the Mexican public in a reasonable time.

Q: How efficient is the process COFEPRIS follows to authorize new molecules including biopharmaceuticals?

A: The current approval process demands laboratories to submit their applications before the New Molecule Committee, which is comprised of independent experts, medical specialists, and notable investigators from Universities and Scientific Academies. This body then presents its opinion to COFEPRIS, which further evaluates the medicine in question. With respect to biotechnological medication, there is a Subcommittee of Biotechnological Products made up of experts in the fields of pharmacology, toxicology, statistics, immunology, and bioethics. This body evaluates the submissions and presents its findings to the New Molecule Committee (NMC) so that they can evaluate the medicines thoroughly. There is also a Subcommittee of Developing Products, which supports pharmaceutical laboratories in developing their products before they are presented to the NMC. All of this ensures that the evaluation of a new molecule by COFEPRIS is carried out comprehensively, and that the efficacy and safety of the medication are systematically examined.

Q: Do you see biotechnological medicine as potentially lucrative for Mexico?

A: The importance of biotechnology medicines is growing in Mexico as well as internationally. Currently, I do not believe it is very lucrative for Mexico since the majority of the national pharmaceutical laboratories are registering biotechnology medicines with active ingredients that are manufactured abroad. At the moment the sale of biotechnological medication comprises between 15% and 17% of the total sales in the pharmaceutical sector, and they are expected they will be 40% and 50% in the next few years. If laboratories in Mexico only manufacture biosimilars with imported raw materials, we will depend on the import prices, making us vulnerable. In turn, this could provoke a shortage of essential life-saving medications for patients with chronic and terminal diseases. At the moment, there is only one laboratory in the country manufacturing biocomparables self-sufficiently.

Q: What are the principal problems faced in the production of biotechnological medications?

A: Biosimilar medications are already being made by major companies alongside innovative products. Moreover, countries with adequate national medication policies like India, China, South Korea, and Brazil perform clinical trials to demonstrate efficacy and safety, using hundreds of test subjects with high cost implications. Disregarding the expense of implementing techniques to produce biosimilars in our country, it is very challenging for a national laboratory to afford clinical trials incorporating the same number of patients. As a result, the only way for Mexico to compete in this field is by following the example of other countries and implementing a national policy for biotechnology medications. At the moment, I am working on a project with FUNSALUD to draft a document setting the requirements for this policy. It is important that Mexican companies develop biosimilars from scratch to produce innovations, as this is what will really bring attention and investment to Mexico.