New regulations in Brazil for the registration of biosimilars

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New regulations in Brazil for the registration of biosimilars

INICIO/Directrices | Posted 15/10/2024 0 Post your comment

In June 2024, Resolution RDC No. 875 was published in Brazil in the Official Journal of the Union (DOU) [1], modifying the current regulation regarding the registration of biological products (RDC 55/2010).

In Brazil, a legal framework for approving follow-on biological products using a comparability pathway was established in 2010 through the Resolution of the Collegiate Board of Directors (RDC) biosimilars regulations, RDC 55/2010 [2], by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).

The resolution of the Collegiate Board - RDC No. 875 of 28 May 2024 - establishes additional provisions on the registration of biosimilars through the development of comparability.

RDC 875/2024 was published to specify the requirements of the comparability development pathway for biosimilars, thereby simplifying the development process for this category of products in Brazil by safely relaxing the requirements. This resolution entered into force on 17 June 2024.

One of the major innovations introduced by the regulation is the possibility of using an international reference drug, provided that it is approved by an Equivalent Foreign Regulatory Authority (AREE), when it is not available on the national market. Another important point is the possibility of dispensing with non-clinical and comparative clinical studies based on the characterization data of the molecule, when technically applicable.

The publication of RDC 875/2024 results from a broad debate between ANVISA and the regulated sector, which began in 2022 with Call 15/2022. Following this Public Notice, ANVISA held a Sector Dialogue in July 2023 to address the issue. In October 2023, Public Consultation (CP) 1206/2023 was published to collect contributions from the regulated sector for the development of the final draft of the Resolution.

It should be clarified that ANVISA uses the terms (a) new biological product for a new biological entity that is not yet registered; and (b) biological product to refer to copy or follow-on products containing an active substance that is already registered [3].

Pharmaceutical market of biological and biosimilar medicines in Brazil

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References
1. https://www.in.gov.br/web/dou/-/resolucao-da-diretoria-colegiada-rdc-n-875-de-28-de-maio-de-2024-562756741
2. GaBI Online - Generics and Biosimilars Initiative. Follow-on biologicals/biosimilars approved in Brazil: May 2023 update [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 15]. Available from: www.gabi-journal.net/follow-on-biologicals-biosimilars-approved-in-brazil-may-2023-update.html
3. GaBI Online - Generics and Biosimilars Initiative. Key facts of biosimilars approval regulation in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 15]. Available from: www.gabionline.net/biosimilars/general/key-facts-of-biosimilars-approval-regulation-in-brazil

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