Cancer Biosimilars—A Regulatory Success So Far, but Value Still to Be Determined
A partir d'une revue systématique de la littérature publiée jusqu'en avril 2021 (31 études, 12 310 patients), cette étude identifie les caractéristiques des essais cliniques évaluant des médicaments biosimilaires pour le cancer et analyse la qualité de ces essais cliniques
In the article accompanying this editorial, Bloomfield and colleagues report a meta-analysis of published clinical trials evaluating 3 disease-modifying biosimilar oncology drugs. Biosimilars are large-molecule, complex drugs that are clinically equivalent to an originator biologic agent, have efficacy and safety equivalent to the originator, and have a regulatory pathway designed to facilitate market entry after the originator’s patent protection and market exclusivity have expired. Market competition and pricing relief, comparable to that which occurs after generic small-molecule drugs enter the market, is the promise of biosimilars. Thirty-one biosimilars are approved for marketing in the US, of which 17 are for cancer-related conditions. The authors identified 3 originators for their meta-analysis: rituximab, trastuzumab, and bevacizumab.