Client Alert

Brazilian FDA calls for contributions on the proposal to change regulation of biosimilars

October 5, 2023

Yesterday, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (called “Anvisa” in the Portuguese acronym) published a call for comments (#1,206 of 2023) to receive suggestions on its proposal to amend the requirements for obtaining marketing authorization (MA) for biosimilars, which are currently governed by Anvisa’s Rule #55/2010.

DICOL unanimously approved the call for contributions during the 27th Ordinary Public Meeting, held on September 27, 2023. As per the vote of Reporting Director Meiruze Freitas (Vote #260 of 20231), the proposal is to facilitate development and MA granting for biosimilars and aims to harmonize Anvisa’s rules with the criteria applied by the foreign regulatory agencies.

Such proposal is another step taken by Anvisa to amend its regulation on biosimilars. In November 2022, the Agency published Call for Proposals #15 of 2022, to gather information from market players regarding the challenges to obtain MAs for biosimilars. In response, companies pointed out as the main obstacles: (i) lack of harmonization of Brazilian regulation in comparison with international guidelines, as the criteria imposed by Anvisa are stricter; (ii) lack of flexibility in terms of the non-clinical and clinical studies required; and (iii) difficulty in obtaining the biological comparator product in the domestic market and the lack of guidance on the selection and use of international comparators2.

Moreover, last July, Anvisa organized a dialogue between its own agents and representatives from players operating in the biosimilars market. The intent was to discuss some of the issues pointed out in the contributions received in response to the Call for Proposals #15 of 2022, and possible solutions3.

The proposal draft for comments addressed some of the issues pointed out by the biosimilars companies. For example, in articles 7 and 8, which establish the need for presenting non-clinical and clinical specific studies, it has been included a provision stating that such studies may be exempted upon presentation of technical-scientific justification submitted to Anvisa and whose reasoning relies on foreign regulatory agency’s guidelines. Finally, regarding the comparator/originator product, article 4 provides for the possibility of purchasing it on the international market, which is no longer conditioned on its unavailability on the domestic market.

The call will have a 45-day period from October 11th, 2023, ending on November 24, 2023. Comments must be sent through an electronic form that will be available at the Agency’s website (link). Foreign companies may physically file their comments at Anvisa’s headquarters in Brasilia.

For more information on the subject, please e-mail us at

1 Portuguese version available at: link.

2 Anvisa published a report analyzing the contributions received in response to the Call for Proposals #15 of 2022. Available at: link.

3 Anvisa published a report describing the discussions in each panel of the Sector Dialogue.Available at: link.

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