Guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals in Brazil

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ANVISA (Agência Nacional de Vigilância Sanitária), the National Health Surveillance Agency of Brazil, published in November 2022 three new guidance documents on the regularization of biological, biosimilar and radiopharmaceutical products.


In 2010, Brazil introduced regulations to specifically address and establish specific pathways to license follow-on biological products using a comparability pathway. The Brazilian regulations (RDC 55/2010) are based on different regulations and guidelines from around the world, including the World Health Organization (WHO) Similar Biological Product Guidelines. They follow the same scientific principles as the WHO guidelines but contain some differences due to the specific needs of Brazil [1].

In November 2022, ANVISA issued three new guidelines to regulate biologicals/biosimilars and radioradiopharmaceuticals. Specifically, there are two technical notes and a Q&A document.

The three guidelines are:
1. Technical Note No. 63/2022/GPBIO/GGBIO - Procedural instructions for registration and post-registration of biological products, which updates the document already available in the portal of ANVISA.  

The document contains information on the request topics applicable to the registration and post-registration of biological products and the different possibilities of request. The technical note also clarifies how the documentation should be organised for submission to ANVISA.

2. Technical Note No. 61/2022/GPBIO - Statement on post-registration of the inclusion of a new route of administration and/or a new posology for biosimilar products.

In this document, ANVISA's technical area responsible for the evaluation of biological products clarifies the possibility of making specific post-registration changes in situations where the comparator product does not have the route of administration or posology required by the biosimilar product.

3. Questions and answers on radiopharmaceuticals

This document aims to clarify questions related to the notification and registration of radiopharmaceuticals. The publication provides clarifications on the current regulations, as well as some of ANVISA's views on the subject. The document includes a total of 54 questions and answers, addressing issues such as important definitions on the subject; exemption from registration and requirements for registration of radiopharmaceuticals; documentation to demonstrate efficacy and safety; and importation and quality control of imported radiopharmaceuticals.

It is important to highlight that this publication is only indicative, that is, it does not imply any change in the current regulations.

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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 Dec 1]. Available from:

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Source: ANVISA

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