A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which\nhinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute\nequivalent of the original medication. The currently available technology does not allow for an accurate copy of complex\nmolecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in\noncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the\nBrazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in\noncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation,\ninterchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial\nburden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective\nalternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to\nsupport therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to\nexpedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for\nfurther discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.
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