Public Consultation on biosimilars medicines opened

Public Consultation on biosimilars medicines opened

Anvisa’s Public Consultation 1.206/2023 was published in the Official Federal Gazette (DOU) on October 4, 2023. The main objective is to amend the current regulation on biosimilar medicines, as well as to completely revoke Chapter V of RDC 55/2010, which establishes the registration of biological products through comparability – Biosimilars.

In general terms, the goal is to simplify the process of developing and regulating biosimilars, in line with scientific and regulatory advances, optimizing specific stages and studies.

Initially, the Public Consultation will be open for 45 days, from October 11 until November 24, 2023, and contributions can be sent via the Agency’s website.

Brief context

The opening of the regulatory process and public consultation was approved at the 15th Ordinary Public Meeting of 2023 (ROP 15/2023) of Anvisa’s Collegiate Board (DICOL).

Prior to the regulatory proposal, the General Management of Biological Products, Radiopharmaceuticals, Blood, Tissues, Organs, and Advanced Therapy Products (GGBIO) carried out a consultation with the regulated sector, through Call Notice 15/2022, aiming to hear from the sector about the main difficulties and challenges present in the development, registration and approval of biosimilars.

In this regard, a Final Report was prepared, which provided information on the marketing of this type of medicine and also allowed for a Sector Dialogue between Anvisa and the regulated sector, at the end of July 2023, which included discussions on points that could be changed in RDC 55/2010.

Finally, after analyzing all this regulatory discussion, the Anvisa’s technical area drew up this proposal for a Public Consultation.

Details of the proposed resolution

The main new features of the proposed RDC include the following:

  • Definition of biosimilar: any biological medicine that contains an active substance that is highly similar to an innovative biological medicine already registered by Anvisa, whose similarity has been based on an extensive comparability assessment, verifying that there is similarity in quality, biological activity, safety and efficacy.
  • Details for the registration application: Chapter V of RDC 55/2010 will be revoked and a proposal on specific studies to be carried out is being incorporated. According to the proposal, biosimilars may be registered using reports that contain:

    (i) studies describing the analytical techniques used to detect potential differences between the biosimilar candidate and the comparator biological medicinal product;

    (ii) biological and physicochemical characterization data related to the quality attributes of the biosimilar candidate;

    (iii) a report containing a detailed description of the stages of the comparability exercise, indicating the ability to detect differences in quality attributes between the biosimilar candidate and the comparator biological medicine, among other points.
  • Clinical information: when applying for registration of the biosimilar candidate, the company must submit complete reports of non-clinical and clinical studies, which must be comparative and designed to detect differences between the candidate and the comparator.
  • Non-clinical studies: among the in vivo non-clinical studies, pharmacodynamic studies relevant to the intended therapeutic indications and cumulative toxicity studies, including toxicity kinetics parameters, should be presented.
  • Clinical studies: among the clinical studies, pharmacokinetic, pharmacodynamic and immunogenicity, safety and clinical efficacy studies should be presented.
  • Equivalent Foreign Regulatory Authorities (AREE): it is possible to use a comparator drug purchased on the international market, as long as it comes from one of the countries regulated by the AREE recognized by Anvisa. This product must have the same manufacturers as the active substance and finished product of the drug registered with Anvisa. Exceptionally, it will be possible to purchase a comparator drug that has different manufacturing sites, in which case a bridging study will be required to relate the product purchased to the one actually registered in Brazil.

It should be noted that Anvisa may require additional proof of identity and quality and of the components of the biosimilar medicine at any time and at its discretion and may also require studies to prove clinical efficacy and safety, in case of facts arising and motivating further evaluation, even after registration.

The proposed rule also aims to revoke articles 19 and 27 of RDC 55/2010.

Consequences and next steps

With the expectation of simplifying the process of developing and registering biosimilar medicines, the proposed regulation will allow the supply of these products to be expanded in Brazil, with a reduction of costs. It is worth noting that this measure is also in line with the missions of the Health Economic-Industrial Complex (CEIS), whose strategy was recently published (for more details, see the material we have prepared via this link).

After the public consultation closes on November 24, the proposal will return to DICOL for a final analysis.

For more details on the subject, contact Souto Correa’s Life Sciences & Healthcare team via e-mail:

I'm a subscriber
I'm a subscriber