Public Consultation for the Modification of the Biosimilars Regulation

by | Oct 9, 2023 | Blog, Life Sciences, Pharma

On October 4, 2023, ANVISA published Public Consultation 1,206/2023 regarding the amendment of the current biosimilar drug regulation. This Public Consultation was approved during a meeting of ANVISA´s Collegiate Board (DICOL) held on September 27, 2023, with the aim of creating a new Collegiate Board Resolution (RDC) to provide supplementary regulations for biosimilar registrations through the comparability development pathway, and to revoke Chapter V of RDC 55/2010, the current governing rule.

This proposal resulted from a diagnostic process and information analysis. Initially, ANVISA engaged with the industry through Public Notice 15, dated November 7, 2022, to gather information on the main difficulties and challenges in the development and approval of biological products via comparison (biosimilars). Subsequently, on July 31, 2023, a Sectorial Dialogue was conducted to discuss specific points that could be amended promptly in RDC 55/2010.

The proposal aims to streamline the development and registration process for biosimilars, allowing for the omission of certain steps or specific studies when technically feasible. It also allows for the use of a comparator drug acquired from the international market (no longer considered an exception), provided it comes from a country regulated by recognized foreign regulatory authorities as acknowledged by ANVISA.

Currently, according to ANVISA’s own data, Brazil has 51 registered biosimilar drugs and approximately 30 products awaiting analysis or already in the technical review process. This suggests that the Brazilian market could soon rank second in terms of registrations, trailing only behind the European Medicines Agency (EMA).

If approved after the public consultation, this measure could increase the capacity to develop new biosimilars in Brazil, reducing costs for the healthcare system and contributing to the goals of the Economic and Industrial Health Complex (CEIS), which we also discuss in our next post about this issue.

Contributions to the Public Consultation can be submitted through a specific form available on the ANVISA website from October 11 to November 24, 2023, as per the initially established 45-day period.

If you have any questions or would like to get more information, do not hesitate to get in touch with our team.

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