Buske Christian, Ogura Michinori, Kwon Hyuk-Chan, Yoon Sang Wook
CCC Ulm, University Hospital Ulm, Ulm, Germany.
Department of Hematology, Tokai Central Hospital, Gifu, Kakamigahara, Japan.
Future Oncol. 2017 May;13(15s):5-16. doi: 10.2217/fon-2017-0153.
Monoclonal antibodies and other biologic drugs play important roles in the treatment of various hematological malignancies and solid tumors. However, such drugs are intrinsically more expensive to develop than small molecules and their clinical benefits are often accompanied by challenges relating to affordability and access. Patent expiry for 'originator' biologics is providing opportunities for a new generation of biosimilar drugs, potentially capable of relieving pressure on healthcare budgets. This article discusses key characteristics of biosimilars, distinguishes them from generics and noncomparable biologics and outlines the robust regulatory requirements that must be followed to establish biosimilarity with a reference product. The path to approval is discussed with reference to the rituximab biosimilar CT-P10, the first licensed monoclonal antibody biosimilar cancer therapeutic.
单克隆抗体和其他生物药物在各种血液系统恶性肿瘤和实体瘤的治疗中发挥着重要作用。然而，与小分子药物相比，此类药物的研发成本本质上更高，而且其临床益处往往伴随着可负担性和可及性方面的挑战。“原创”生物制剂的专利到期为新一代生物类似药提供了机会，这类药物有可能缓解医疗保健预算的压力。本文讨论了生物类似药的关键特性，将它们与仿制药和不可比生物制剂区分开来，并概述了为证明与参比产品具有生物相似性而必须遵循的严格监管要求。文中还参照首个获得许可的单克隆抗体生物类似药癌症治疗药物利妥昔单抗生物类似药CT-P10讨论了获批途径。
