To conduct a comparative study of the health registration regulations for biological and biotechnological drugs in Latin America, Ramírez-Telles et al. made an approximation, as clear as possible, of biological terms: regulatory authority of reference, biotechnological drug, reference biological drug and innovative product. Its objective was to detect the differences and what these variations entailed when comparing the following Latin American countries: Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama .
Some of the basic aspects that were requested from one or more of the regulations in these nine Latin American countries included the definitions of the following concepts:
Reference regulatory authority
The National Regulatory Authority (NRA) is responsible for establishing its own regulatory framework for the registration and marketing of biological and biotechnological products. NRAs must in turn show compliance with the recommendations made by the World Health Organization (WHO). Four levels of development have been established, Level IV being the one that allows the Pan American Health Organization (PAHO) to designate the Regulatory Agency as the Reference Authority for Medicines and Biological Products.
Biotechnological drugs are obtained by inserting genetic material into living organisms, using recombinant DNA technology, so that they become producers of the required protein or recombinant protein.
Most of the countries of Central America, the Caribbean and some of South America have a specific description for the concept of biotechnological product, whereas a few countries only offer the definition of biological product.
Reference biological drug
For the definition of reference biological drug or reference product, each Latin American country establishes its own specific definition; therefore, when a comparison is made, its scope differs significantly from one country to another.
In countries that do not include this definition, it is more difficult to conduct a study to demonstrate the biosimilarity analysis, since there is no criterion for comparison between products with the same active ingredient that are intended to be commercialized in one of these markets.
The definition of innovative product also varies considerably among the legislations of each country.
Table 1 below shows the information obtained regarding these four basic concepts that were requested in one or more of the regulations and for each of the countries studied.
| Table 1: Information required in the current regulations for the health registration of biological and/or biotechnological products in nine Latin American countries*
| Information on the biological and/or biotechnological product
|| Central America and Caribbean countries, Brazil and Chile
| List of reference regulatory authorities
Only Dominican Republic, El Salvador and Guatemala indicate the name of the reference regulatory authority and fall within the definitions delimited as Stringent Regulatory Authority
Costa Rica applies the recognition of the evaluation and approval of final reports of clinical and non-clinical studies by the reference regulatory authorities as evidence for the health registration of medicines
Honduras, although the definition of reference regulatory authority is not included, it is required that the product has been previously registered by a reference regulatory authority
| Definition of biotechnological medicine
Panama and Cuba do not present a description of the concept of biotechnological product per se, but of biological product
Costa Rica, Brazil, Chile, El Salvador, Guatemala, Honduras and Dominican Republic mention key aspects of this type of pharmaceutical product
| Definition of reference biological drug
Each country establishes its own definition
Only Honduras does not include this definition
| Definition of innovative drug or innovative product
Brazil, Chile, Cuba and Honduras do not have this concept in their regulations.
Costa Rica and Guatemala corresponds to that which was first authorized for marketing in the first country of origin
For the Dominican Republic and Guatemala, the innovative product is the product to be used as a reference
For Cuba, an innovative product must be one that has been on the market for less than five years
| *Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, and Panama.
In the general information requested from the regulations for the health registration of biological and biotechnological products, relevant variations and differences were found in the definitions of regulatory authority of reference, biotechnological drug, reference biological drug, and innovative product. Thus, after reviewing and comparing the regulations regarding the health registration of biological and biotechnological products in the nine Latin American countries, it was found that the information requested is not standardized .
More information on biological terms can be found in the article published by GaBI Online entitled Glossary of key terms .
Readers interested to learn more about biosimilar regulation implementation in Latin America are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Recomendaciones para la reglamentación de biosimilares y su implementación en Latinoamérica
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1. Ramirez-Telles M, Mora-Roman Jose J, Fallas-Cartin M. Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina. Ars Pharm. 2021;62(2):131-43.
2. GaBI Online - Generics and Biosimilars Initiative. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 3]. Available from: www.gabionline.net/es/biosimilares/general/glosario-de-terminos-principales
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