Khraishi Majed, Stead David, Lukas Milan, Scotte Florian, Schmid Holger
Clinical Professor of Medicine (Rheumatology), Memorial University of Newfoundland, Canada.
Recently retired Medicines Procurement Specialist Pharmacist NHS South West and past Chairman of Pharmaceutical Market Support Group.
Clin Ther. 2016 May;38(5):1238-49. doi: 10.1016/j.clinthera.2016.02.023. Epub 2016 Mar 14.
A biosimilar is an officially regulated and approved copy of an originator biologic therapy. Improved affordability and consequent wider patient access compared with biologics are a significant appeal of biosimilars. Regulatory guidelines for biosimilar development and approval are rigorous and undergoing constant refinement. The process of licensing approval for all biosimilars requires demonstration of comparability in quality, efficacy, and safety between the biosimilar and reference (originator) product, which is undertaken in a stepwise procedure of nonclinical and clinical evaluation. The approval of >20 biosimilars in Europe in several drug classes, including the first monoclonal antibody biosimilar, bears testimony to the increasing regulatory acceptance of these agents. In contrast, the clinical application of biosimilars remains underrecognized by physicians across therapy areas. Therefore, this article aims to provide a comprehensive review of the biosimilar development process and to provide multidisciplinary guidance on the potential therapeutic utility of biosimilars in clinical practice. Specifically, experts discuss clinical developments in the introduction of biosimilars across the disciplines of gastroenterology, nephrology, oncology, and rheumatology, and from a payer perspective, and also highlight a common need for ongoing pharmacovigilance, robust head-to-head clinical studies, and real-world data to establish the long-term risk-benefit profile of biosimilars. In conclusion, significant potential exists for biosimilars to revolutionize biologic therapy by widening patient access across therapy areas.
生物类似药是原创生物疗法的官方监管并获批的仿制品。与生物制品相比，其可负担性提高，从而使更多患者能够使用，这是生物类似药的一大显著吸引力。生物类似药研发和审批的监管指南十分严格且在不断完善。所有生物类似药的许可审批过程都要求证明生物类似药与参比（原创）产品在质量、疗效和安全性方面具有可比性，这要通过非临床和临床评估的逐步程序来进行。欧洲已批准了20多种不同药物类别的生物类似药，包括首个单克隆抗体生物类似药，这证明监管机构对这些药物的接受度在不断提高。相比之下，生物类似药在各治疗领域的临床应用仍未得到医生的充分认可。因此，本文旨在全面综述生物类似药的研发过程，并就生物类似药在临床实践中的潜在治疗效用提供多学科指导。具体而言，专家们从胃肠病学、肾脏病学、肿瘤学和风湿病学等学科以及支付方的角度讨论了生物类似药引入过程中的临床进展，还强调了持续进行药物警戒、开展有力的头对头临床研究以及获取真实世界数据以确立生物类似药长期风险效益概况的共同需求。总之，生物类似药有很大潜力通过扩大各治疗领域患者的可及性来变革生物疗法。
