Public consultation for the modification of the biosimilars regulation in Brazil

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The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) initiated a public consultation on expediting regulation of biosimilar drugs. The goal is to decrease dependence on high-cost imported biological medicines and position Brazil as a significant regional exporter of lower-cost biological therapies.

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On 4 October 2023, ANVISA published Public Consultation #1,206/2023 regarding the amendment of the current requirements for obtaining marketing authorization for biosimilars, which are governed by ANVISA’s Rule #55/2010. This Public Consultation was approved during a meeting of ANVISA´s Collegiate Board (DICOL) held on 27 September 2023.

At that meeting, officials with ANVISA announced a public comment period concerning a proposed rule change that would, if adopted, ease the path by which biological and biosimilar drugs receive marketing authorization.

Following two recent conferences organized by ANVISA involving stakeholders, the agency evaluated the pros and cons of waiving the requirement for non-clinical and clinical studies in the review of marketing applications for biosimilars, interchangeability, and international references.

The proposed draft for comments outlines the potential exemption of non-clinical and clinical specific studies, contingent upon the submission of a technical-scientific justification to ANVISA. This justification should be based on guidelines from foreign regulatory agencies. Additionally, the draft permits the use of a comparator drug sourced from the international market (no longer considered an exception), provided it originates from a country regulated by recognized foreign regulatory authorities, as acknowledged by ANVISA.

The move was in line with expectations, as ANVISA had previously outlined in an August 2022 report that regulatory reliance would play a pivotal role in its strategy to enhance the production and accessibility of biosimilars.

The public consultation on the Resolution of the Collegiate Board of Directors (RDC) was to amend the national regulation of biosimilar medicines and revoke Chapter V of RDC 55/2010, which provides for the registration of biological products by way of comparability (biosimilars). The Brazilian regulations follow the same scientific principles as the World Health Organization (WHO) guidelines but contain some differences due to the specific needs of Brazil [1]. 

The proposal seeks to simplify the process of developing and registering biosimilars, recognising the possibility of dispensing with specific steps or studies when technically feasible.  

If approved following the public consultation, this measure has the potential to expand the capacity to develop new biosimilars for the Brazilian population, reducing costs for health systems and also contributing to the objectives of the Health Economic and Industrial Complex (HEIC). 

The proposal aims to modernise national regulations and harmonise the discussion with an international scope, bringing the need to present some studies to the scientific field and preparing ANVISA to receive future registration applications. It also aims to clarify certain points by improving and updating the text of RDC 55/2010, with the potential to increase the speed of development and the availability of biosimilars in the country.

The public consultation is open for contributions for 45 days from 11 October to 24 November 2023. Once the public consultation has been finalised, the rapporteur for the proposal will be the CEO, Antonio Barra Torres.

By May 2023, Brazil has 52 follow-on biological medicines and approximately 30 biological products awaiting analysis or already being analysed by ANVISA [2, 3]. This indicates that Brazilian biosimilar approvals have surpassed those of the US FDA, which has approved 45 biosimilars, placing Brazil in second position globally for biosimilar approvals, behind only the European Medicines Agency.

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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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1. GaBI Online - Generics and Biosimilars Initiative.  Guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals in Brazil []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 16]. Available from:
2. Cestari de Oliveira SH. Follow-on biologicals/biosimilars approved in Brazil: May 2023 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(2):67-72. doi:10.5639/gabij.2023.1202.012
3. GaBI Online - Generics and Biosimilars Initiative.  First approvals of similar biotherapeutics in seven Latin American countries []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 16]. Available from:

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