Randomized clinical trials to register biosimilar trastuzumab drugs: a scoping review, Brazil, 2020

• Autor(a) principal: Fazza Kelmer, Tamiris
• Data de Publicação: 2021
• Outros Autores: Sobreira da Silva, Mario Jorge, Peçanha Favero Retto, Maely
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1921
• topic: Breast Cancer; Trastuzumab; Biosimilar; Biosimilars; Oncology; Register; Neoplasia de Mama; Trastuzumabe; Biossimilar; Biossimilares; Oncologia; Registro; Biosimilar; Oncología; Registro

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 .