Annovazzi Pietro, Bertolotto Antonio, Brescia Morra Vincenzo, Gasperini Claudio, Montanari Enrico, Navarra Pierluigi, Patti Francesco, Sormani Maria Pia, Ghezzi Angelo
Multiple Sclerosis Study Center, ASST Valle Olona, Gallarate, VA, Italy.
Neurology and Multiple Sclerosis Regional Reference Center (CRESM), AOU San Luigi, Orbassano, Italy.
Neurol Ther. 2017 Dec;6(2):161-173. doi: 10.1007/s40120-017-0079-3. Epub 2017 Jul 31.
Economic sustainability is of paramount importance in the rapidly evolving therapeutic scenario of multiple sclerosis (MS). Glatiramoids are a class of drugs whose forefather, glatiramer acetate, has been used as a disease modifying drug (DMD) in patients with MS for over 20 years. Its patent expired in 2015; new versions of such drug are nowadays available on the market, potentially contributing to lowering prices and enhancing a better allocation of economic resources. In this review, we analyze the recommendations underlying the approval of both generic drugs and biosimilars by regulatory authorities, and we provide methodological tools to contextualize the design of studies on these new classes of drugs. We examine in more detail the preclinical and clinical data of Copemyl, a new member of the glatiramoid class, focusing on its biological and immunological properties and illustrating randomized controlled trials that led to its authorization.
在快速演变的多发性硬化症（MS）治疗方案中，经济可持续性至关重要。格拉替雷类药物是一类药物，其鼻祖醋酸格拉替雷已作为疾病修正药物（DMD）用于MS患者超过20年。其专利在2015年到期；如今该类药物的新版本已在市场上有售，这可能有助于降低价格并更好地分配经济资源。在本综述中，我们分析了监管机构批准仿制药和生物类似药的相关建议，并提供了方法学工具，以便将这些新型药物的研究设计置于背景之中。我们更详细地研究了格拉替雷类新成员考培美（Copemyl）的临床前和临床数据，重点关注其生物学和免疫学特性，并阐述了使其获得批准的随机对照试验。
