Green light from ANVISA regarding the registration of biosimilar medicines in Brazil

The National Health Surveillance Agency (ANVISA) has approved the opening of a Public Consultation to amend the regulation of biosimilar medicines in Brazil and revoke Chapter V of Collegiate Board Resolution 55/2010 (RDC 55/2010), which addresses specifically the registration of biosimilars.

Biosimilar products are developed in such a way as to guarantee the same results in terms of safety, quality and efficacy as an existing drug, already approved by the regulatory bodies. They are biological medicines, while generics are produced by chemical synthesis. Under the terms of Chapter V of RDC 55/2010, the application for registration of a biological product via the development by comparability route (biosimilars) must submit a series of comparative studies.

Since 2022, ANVISA has been collecting information on the obstacles to the development and approval of biosimilars in Brazil. That same year, a consultation was addressed to the production sector, through a Public Notice No. 15 of November 7th, 2022. More recently, the need to modernize RDC 55/2010 in order to follow an international trend of flexibility of registration criteria gained more strength after a Sector Dialogue was held. Based on the study of the information collected, a draft regulation was drawn up and sent to the Collegiate Board for discussion.

With this in mind, the purpose of the public consultation is to simplify the development and registration process, recognizing the possibility of exempting specific stages or studies when technically acceptable. The idea is to simplify the regulatory procedure for registering biosimilars, starting with the revocation of chapter V of RDC 55/2010.

ANVISA believes that this change will bring benefits not only to the companies that are applying to register the product, but also to the market; since by simplifying the procedure, there would be the possibility of expanding the development of new biosimilars available to society. Thus, a positive cycle would be generated, allowing for a reduction in costs to the health system, and also contributing to the purposes of the Health Economic and Industrial Complex (in Portuguese – Complexo Econômico e Industrial da Saúde – Ceis).

According to the vote of the Director of the Second Board, Mrs. Meiruze Souza Freitas, the proposal to fast-track this process will enable the Brazilian market to achieve a new position in terms of the number of drug registrations worldwide. Brazil, which currently has 51 registered biosimilar medicines and 30 products awaiting analysis; or awaiting finalization of the analysis by ANVISA’s technical area, would reach second place in terms of the number of registrations in the world ranking, and would be second only to the European Medicines Agency (EMA).

In view of the importance of the subject, it is essential that interested companies offer contributions to the public consultation, which has been announced as lasting 45 days (with no confirmation yet of the exact closing date), in order not to miss the opportunity to express their opinions and present data to the Agency that corroborates the importance of the registration criteria currently in force being maintained or made more flexible to a certain extent.

For more content related to ANVISA and other developments regarding the Public Consultation, don’t hesitate to contact us at regulatorio@kasznarleonardos.com.