Key facts of biosimilars approval regulation in Brazil

Biosimilars/General | Posted 18/11/2022 post-comment0 Post your comment

This article provides a brief overview of the important aspects and an update on the regulatory pathways for approval of biological products in Brazil [1].


Brazil was in 2010 the first Latin American country in regulating biosimilars [2]. The approval and registration of biological medicines in Brazil are regulated by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, 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 [3]. 

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 [3].

Biosimilars are those biological products registered through development by comparability, which is the regulatory pathway used by a biological product or medicinal product to obtain registration, in which the comparability exercise in terms of quality, efficacy and safety between the product developed to be comparable and the comparator biological product was used, according to the definition of ANVISA [4]. Biosimilars still nowadays go through a strict examination as well as in countries outside the US and EU.

According to the RDC 055/2010 for establishing the criteria for follow-on biological approval in Brazil, there are two regulatory pathways for non-originator biologicals: (1) comparability (biosimilar) – a stepwise approach; and (2) stand-alone (non-biosimilar), however, only the comparability pathway is for the approval of biosimilar product. Table 1 shows the Regulatory pathways for registration of biological products by ANVISA, previously, biological product approved under the comparability is termed as ‘follow-on biologicals’ [1].

Table 1:  Regulatory pathways for registration of biological products by ANVISA
Parameters New biological product (originator) Biological product
Comparability (biosimilar) Stand-alone (non-biosimilar)
Chemistry, manufacturing and controls data Required Comparative According to standards
Preclinical studies Required Comparative Can be reduced
Clinical studies – Phases I and II Required Comparative When needed, no need to be comparative
Clinical studies – Phase III Required Comparative Comparative, with exceptions (Blood derivatives, vaccines, and oncological drugs)
Immunogenicity studies Required Comparative Required
Comparator product Not Applicable Yes Not specified
Pharmacovigilance Required Required Required
Extrapolation of indications Not applicable Possible Not possible
Updated 18 November 2022.
Source: ANVISA (Agência Nacional de Vigilância Sanitária).


The first biosimilar approved by ANVISA was Celltrion’s Remsima (infliximab) (CT-P13) in April 2015 [5]. To date, 43 follow-on biologicals/biosimilars (from five different classes) on 13 different innovator biologicals have been approved in Brazil by ANVISA.

ANVISA approved its first follow-on biological totally manufactured in Brazil in October 2015, Eurofarma’s Fiprima (filgrastim), and its first follow-on biological developed, manufactured and commercialized in Brazil in May 2019, Cristália’s Criscy (somatropin) [6].

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The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

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1. GaBI Online - Generics and Biosimilars Initiative. Regulatory pathways for approval of biological products in Brazil []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Brazilian market of biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Nomenclature of biologicals and biosimilars in Brazil []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Market outlook for biological medicines in Brazil 2016-2025 []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from:
5. GaBI Online - Generics and Biosimilars Initiative. Follow-on biologicals and extrapolation in Brazil []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from:
6. Cestari de Oliveira SH, Castanheira Alegria M, Stephano MA. Brazilian regulation of biosimilar products: what is important to know.BioPharm Int. 2022 Sep;30-7.

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