Abstract
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.
Highlights
IntroductionSince the approval of recombinant insulin – the first biopharmaceutical (biological product) approved by the US Food and Drug Administration (FDA) in 1982 – over 160 biological drugs and vaccines have been licensed in the United States alone
Since the approval of recombinant insulin – the first biopharmaceutical approved by the US Food and Drug Administration (FDA) in 1982 – over 160 biological drugs and vaccines have been licensed in the United States alone.Unlike simple drugs composed of small molecules, whose structure and characteristics are well-defined, biopharmaceuticals are derived from the application of biotechnology to industrial manufacturing of active substances from cells and/or microorganisms that are genetically manipulated to produce the drug
We address a range of issues pertaining to biosimilar development and application in Brazil
Summary
Since the approval of recombinant insulin – the first biopharmaceutical (biological product) approved by the US Food and Drug Administration (FDA) in 1982 – over 160 biological drugs and vaccines have been licensed in the United States alone. The introduction of monoclonal antibodies into healthcare practice has significantly improved the overall survival of cancer patients, while in general being less cytotoxic and having milder side effects compared to chemotherapeutic agents, and delivering precise target-directed treatment One such drug is trastuzumab, which inhibits the expression of human epidermal growth factor receptor (HER2). The alternative is to focus on producing sufficient evidence of similarities in chemical composition and biologic activity, through rigorous preclinical analytical validation, followed by safety and efficacy studies in patients (clinical phases) so that the safety data can be the same used for the reference biopharmaceutical [8,9]. Fiprimas (filgrastim), a medication that is used to stimulate the proliferation and differentiation of granulocytes, is the first biosimilar developed in Brazil, approved by ANVISA in 2015 [10]
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