Randomized clinical trials to register biosimilar trastuzumab drugs: a scoping review, Brazil, 2020
DOI:
https://doi.org/10.22239/2317-269X.01921Keywords:
Breast Cancer; Trastuzumab; BiosimilarAbstract
Introduction: Breast cancer has high incidence rates in Brazil and worldwide and it is estimated that about 20% of them are classifed as Human Epidermal Growth Fator Receptor – tipo 2-positive (HER2-positive). For the treatment of this type of cancer, the use of targeted therapies is indicated, using biological drugs, among them, trastuzumab. As it is considered a high-cost drug, the entry of biosimilars into the market can reduce costs to health care services. Objective: To analyze the phase III clinical studies of biosimilar trastuzumab approved in Brazil until 2020. Methods: A scoping review was conducted with clinical trials used to register biosimilar trastuzumab drugs at Anvisa. The data were analyzed regarding: i) treatment protocols involved in the studies; ii) endpoints and investigated population features; iii) biosimilar drugs safety profle. Results: Six randomized clinical trials were selected, analyzed, and compared. The studies were carried out with different treatment protocols, endpoints and drugs. The complete response rate was analyzed in most studies, followed by the complete pathological response. Regarding the investigated population, the studies involved the analysis of the intention-to-treat population and/or per-protocol. In all studies, the biosimilar safety profle was similar to that of the reference drug. Conclusions: The analyzed studies were able to demonstrate similarity between biosimilars and the reference drug regarding safety and efcacy; however, they showed differences in their methodology, population and outcomes analyzed .
Downloads
Downloads
Published
Issue
Section
License
Copyright (c) 2021 Health Surveillance under Debate: Society, Science & Technology (Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnología) – “Visa em Debate”
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
