Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Department of Quality Measurements and Research, Chief Physician's Office, Clalit Health Services, Tel Aviv, Israel.
Br J Dermatol. 2017 Dec;177(6):1495-1502. doi: 10.1111/bjd.15756. Epub 2017 Nov 27.
The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies.
生物药物的引入彻底改变了银屑病的治疗模式，使众多患者能够控制疾病，同时具有可接受的安全性。然而，生物制剂的高成本限制了全球大多数患者获得这些药物的机会。近年来，生物类似药在炎症性疾病中的应用已成为一个快速发展的领域。生物类似药的未来应用有望降低成本，增加银屑病患者获得生物制剂的机会。为了批准生物类似药，不同的监管机构使用高度可变的方法来定义、生产、批准、营销和上市后监测。由于生物制剂和生物类似药之间存在潜在的可互换性，需要进行溯源和药物警戒，以收集关于银屑病患者不良事件的准确数据；自发报告、登记和使用“大数据”应有助于在全球范围内实现这一过程。本文介绍了生物类似药监管指南以及全球多个国家在临床实践中采用生物类似药的实例。由于生物疗法的治疗决策可能变得更加不依赖于医生，国际银屑病理事会建议皮肤科医生应在各自的医疗保健环境和政府机构中积极参与生物类似药处方政策的制定。
