New Regulation Approved by Anvisa Simplifies the Registration Process for Biosimilar Medicines

Anvisa approved the new simplified regulation for the registration of biosimilar medicines, whose publication in the Official Gazette (DOU) is still awaited.

The objective of the new rule approved during the ordinary public meeting of Anvisa’s Collegiate Board (DICOL) on Monday, May 27th, is to simplify the process for biosimilar, starting with the safe contemporizing of development requirements. The regulatory text allows the comparability route from a comparator acquired abroad, the exemption of clinical studies, when technically feasible, and consequently the reduction of documents submitted by the applicant for registration.

The revoked Chapter V of Collegiate Board Ordinance (RDC) No. 55/2010, listed a series of documents necessary for the approval of the registration of these medicines via comparability. Within the collection of required documentation, the idea of the need for a nationally acquired comparator and clinical studies reports of effectiveness and comparability was extracted.

On the contrary, the new proposal brought several simplifications, for example, expressly allowing the use of a comparator acquired abroad through the performance of a bridging study, guaranteeing predictability and legal certainty to developers of biosimilar medicines, avoiding the receipt of requirements that have a risk of not being fulfilled within the legal deadline due to its complexity. Not only that, the new regulatory text, in exceptional cases, when it is possible to confirm the unavailability of the comparator in the national and international market, allows the use of the simplified method of registration of comparability by the Equivalent Foreign Regulatory Authorities (AREEs).

The new regulation was the result of studies initiated in 2022, with the preparation of Call Notice No. 15/2022, responsible for gathering important information and subsidies for the development of biological products by the comparability route.

The rule was also the subject of Public Consultation No. 1,206 for 45 days. In the consultation, 47% of contributions were accepted, with 21% fully accepted and 26% partially accepted, ensuring the essential steps for understanding and improving the regulatory proposal.

If you wish to know more about the health and regulatory developments related to the new regulatory framework for the registration of biosimilars, contact our team: regulatorio@kasznarleonardos.com.