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

Home/Guidelines | Posted 01/12/2022 post-comment0 Post your comment

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.

ANVISA V22A14

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.

https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/medicamentos/produtos-biologicos/documentos-orientativos-e-guias/nt-63_2022_gpbio_instrucao-processual.pdf

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.

https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/medicamentos/produtos-biologicos/documentos-orientativos-e-guias/nt-61_2022_gpbio_biossimilares.pdf

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.

https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/medicamentos/radiofarmacos/documentos-orientativos-e-guias/pr_rf_rdc_451_v27-10-22_revggbio-1.pdf

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

Related articles
Key facts of biosimilar approval regulation in Brazil

Nomenclature of biologicals and biosimilars in Brazil

Market outlook for biological medicines in Brazil 2016-2025

LATIN AMERICAN FORUM
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.

View the latest headline article: Directrices para la regulación de biológicos, biosimilares y radiofármacos en Brasil

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
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.

Ver el último artículo de cabecera: Directrices para la regulación de biológicos, biosimilares y radiofármacos en Brasil

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

  

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Regulatory pathways for approval of biological products in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from:
www.gabionline.net/reports/Regulatory-pathways-for-approval-of-biological-products-in-Brazil

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

 

Source: ANVISA

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010