This article addresses with the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil, the study of which was carried out in 2021 by Maritza Iglesias Galiano of the Universidad Peruana Cayetano Heredia in Lima, Peru.
More broadly, the author analysed in this study the nomenclature of both types of drugs in reference countries, in the region and in Peru, and their implementation proposals.
To do this, author Maritza Iglesias Galiano first conducted an analysis of the regulation referred to the nomenclature issued by the Health Authorities of reference countries such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Therapeutic Goods Administration (TGA) of Australia, Health Canada, Japan's Pharmaceuticals and Medical Devices Agency, and the proposals of the World Health Organization (WHO). Next, the experiences of several countries in the region with level IV health authorities according to the classification of the Pan American Health Organization (PAHO) and which have implemented guidelines for the authorization of biotechnological and biosimilar medicines such as Brazil, were discussed. Finally, the regulation of Peru was studied based on the guidelines implemented for the authorization of biotechnological and biosimilar medicines and the scope of the nomenclature .
In Brazil, the approval and registration of biological medicines are regulated by the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA) through the Resolution of the Collegiate Board of Directors – RDC no. 055/2010 , which specify the minimum requirements to submit an application for registration of new and follow-on (copies) biological products, such as submission of a complete dossier containing information on production, quality control and also a report of clinical and non-clinical data.
ANVISA uses the terms of: (a) new biological product, for a new biological entity not yet registered; and (b) biological product, referring to the copy or follow-on products containing an active substance already registered.
The purpose of this nomenclature is to make clear that biosimilarity is not necessarily a precondition for approval of copies of biological products. Notwithstanding using the denomination of ‘biological products’ for copies, whether they are similar or not, is confusing and, therefore, is considered inappropriate .
As presented in Table 1, ANVISA has not adopted the WHO recommendations nor the FDA model and considers the same International Nonproprietary Name (INN) of the active substance of the innovator drug in authorized biosimilars. This differentiation is needed to ensure the necessary traceability for safety evaluations and to offer the prescribing doctor the option to designate the product to be dispensed .
| Table 1: Health regulation of the nomenclature of biologicals and biosimilars by ANVISA in Brazil
| Health regulation
|| Nomenclature criteria
| RDC 055/2010
– Does not issue guidelines
– Maintains the same INN of the innovator biological medicine in authorized biological medicines
– Does not use the term 'biosimilar'
Data updated on 21 February 2022.
ANVISA: Agencia Nacional de Vigilancia Sanitaria; INN: International Nonproprietary Name.
The first biosimilar approved by ANVISA was Remsima (CT-P13) in April 2015. To date, ANVISA has approved 30 biosimilars in total .
This article is the first in a series of articles on the nomenclature of biological and biosimilar medicines in several Latin American countries.
Pharmaceutical market of biological and biosimilar medicines in Brazil
Differences in immunogenicity, pharmacovigilance and legal documents in biological products in Latin America
Regulations of the registration of biosimilars in Latin America
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1. Iglesias Galiano M. Situación de la nomenclatura de biológicos y biosimilares en países de referencia, países de la región y del Perú propuestas de implementación. 2021.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 25]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-brazil
3. De Assis MR, Pinto V. Strengths and weaknesses of the Brazilian regulation on biosimilars: a critical view of the regulatory requirements for biosimilars in Brazil. Ther Adv Musculoskelet Dis. 2018;10(12):253–9.
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