Data/hora: 10/06/2024 11:38:45

Provedor de dados: | 56
País: | Brazil
Título: | The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC)
Autores: | Fernandes,G.S.; Sternberg,C.; Lopes,G.; Chammas,R.; Gifoni,M.A.C.; Gil,R.A.; Araujo,D.V.
Data: | 2018-01-01
Ano: | 2018
Palavras-chave: | Immunobiologicals; Therapeutic antibodies; Biosimilar; Cancer management; Access.
Resumo: | A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.
Tipo: | Info:eu-repo/semantics/other
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2018000300401
Editor: | Associação Brasileira de Divulgação Científica
Relação: | 10.1590/1414-431x20177214
Formato: | text/html
Fonte: | Brazilian Journal of Medical and Biological Research  v.51 n.3 2018
Fonte: | info:eu-repo/semantics/openAccess