Mellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Mult Scler. 2019 Oct;25(12):1560-1565. doi: 10.1177/1352458519845106. Epub 2019 May 10.
Medication prices are a major contributor to the high cost of care for multiple sclerosis. Three generic glatiramer acetate products have regulatory approval in North America, Europe, or Latin America. The pending expiration of patents for other disease-modifying therapies for relapsing multiple sclerosis creates the opportunity for development and regulatory approval of additional follow-on alternatives (generics or biosimilars), potentially providing lower prices and cost savings to payors and patients. However, the complexities of development, regulatory approval, and marketing of follow-on products have some important differences compared to those of new drugs. This topical review provides background and a status update on the development of follow-on disease-modifying medications to treat multiple sclerosis.
药物价格是导致多发性硬化症治疗费用高昂的主要因素之一。三种通用的那他珠单抗产品已在北美、欧洲或拉丁美洲获得监管批准。其他用于治疗多发性硬化症复发的疾病修正疗法的专利即将到期，这为开发和监管批准更多后续替代药物（仿制药或生物类似药）创造了机会，这可能为支付方和患者提供更低的价格和成本节约。然而，与新药相比，后续产品的开发、监管批准和营销的复杂性存在一些重要差异。本文就开发用于治疗多发性硬化症的后续疾病修正药物的背景和最新进展进行了综述。
