Regulation of Biotechnological Medicines

On May 21, 2019, Pharmacy Graduate Mary Carmen Chuquimia Socpaza, Pharmaceutical Manager of SCR CONSULTORES Bolivia Headquarters, attended the technical meeting "Regulation of Biotechnological Drugs" organized by the Bolivian National Chamber of Commerce, which had as Speaker Dr. Thomas Schreitmueller, Head of the Regulatory Policy Group at Roche Pharma Technical Operations – Hoffman La Roche-Ltd (Switzerland).

The objective of the meeting was to provide technical knowledge on the regulatory framework for the authorization of biotechnological and biosimilar medicines in Europe; in order to establish the requirements and procedures for its pharmacological and pharmaceutical evaluation; as well as the implementation of a manual to obtain the Sanitary Registry of this type of medicines, in Bolivia.

In the development of the meeting, the difference that exists between chemical synthesis, biotechnological, and biosimilar medicines was discussed; in order to explain the importance of the requirement of certain regulatory requirements, such as clinical studies, that ensure the safety and efficacy of the mentioned drugs, at the time of their registration in the health registry and during their commercialization in the country.

Likewise, regarding the regulatory scenario in the countries of the European Union for biotechnological and biosimilar medicines; It was mentioned that due to their complexity and heterogeneity, the European Union has developed a specific regulatory framework based on different and more complex principles compared to chemical synthesis drugs. The European Medicines Agency (EMA) is the body in charge of authorizing biotechnological medicines in Europe through a centralized procedure; this Agency has been a pioneer worldwide in the development of a regulatory framework that establishes the requirements for the authorization of these medicines; and some countries like Australia, Canada, Switzerland or Japan have followed its principles. In fact, in 2010 the World Health Organization published a biosimilar evaluation guide (Similar Biotherapeutic Product Guideline) based on the EMA model with the aim of achieving global harmonization.

In relation to the evaluation procedure of applications for registration in the Sanitary Registry of biotechnological and biosimilar drugs in these countries; It was mentioned that these are evaluated by the Committee for Medicinal Products for Human Use (CHMP), which is made up of representatives of each of the drug regulatory authorities of the European Union and by expert members in the areas of special interest. This committee issues a scientific opinion that is transmitted to the EMA; who is in charge of issuing the final decision. The marketing authorization by this procedure is valid in all the countries of the European Union and the European Economic Area.

Finally, it is important to note that biologic drugs manufactured and generated based on advances in biotechnology have transformed the outlook for patients with numerous often disabling chronic diseases, such as diabetes, cancer, and autoimmune diseases. On the other hand, the scientific-technological development for its production is advancing rapidly; Therefore, it is necessary to establish regulations for the sanitary registration of this type of product in Bolivia.