Department of Neurology and Department of Pediatrics, UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.
Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Mile End Rd, Bethnal Green, London E1 4NS, United Kingdom.
Mult Scler Relat Disord. 2023 Sep;77:104841. doi: 10.1016/j.msard.2023.104841. Epub 2023 Jun 19.
The treatment paradigm for multiple sclerosis (MS), particularly relapsing-remitting MS, is heavily reliant on biologic disease-modifying therapies (DMTs). However, the current cost of treatment acts as a significant barrier to access for patients. Over the next few years exclusivity periods for key biologic medicines used in MS are likely to end, opening the door for biosimilar medicines to enter the market.
In this review, we discuss what biosimilar medicines are, and how the existing experience with biosimilar medicines across multiple therapy areas can inform the assimilation of biosimilar medicines into the MS treatment landscape in Europe and the US.
There is currently a lack of knowledge and awareness around the distinctions and similarities between small molecules, non-biological complex drugs, and biological medicines, as well as the different categories of follow-on successor medicines. These include biosimilar medicines that offer a matching efficacy and safety profile to the reference biologic. Understanding and recognition of the stringency of the approval pathways required for drug categories such as biosimilars are key in building confidence in treatment outcomes. For example, biosimilar medicines are sometimes perceived only as 'copies' of their reference biologic despite undergoing an extensive approval process requiring that no clinically meaningful differences are observed between the biosimilar medicine and the reference medicine. For MS, introduction of biosimilar medicines in the future will enable more people with MS to receive effective treatment, and also expand access to biologic DMTs in MS. Experiences from the use of biosimilars in multiple therapy areas have shown us that this can result in cost-saving benefits for a healthcare system. Introduction of biosimilar medicines in other therapy areas has also demonstrated the importance of appropriate, accurate education and information for their successful integration into clinical practice.
In order to realize optimized treatment outcomes in MS in coming years and to find the appropriate place for biosimilar medicines in the changing MS landscape, it is essential that clinicians and people with MS understand the fundamentals of biosimilars, their potential benefits and consistency of treatment provided by a biosimilar medicine, given the matching efficacy and safety profile to its reference medicine. As evidenced in other therapy areas, biosimilar medicines may reduce key barriers to access by providing a cost-effective alternative to the MS treatment arsenal, while providing the same treatment outcomes as reference biologics.
多发性硬化症（MS）的治疗模式，特别是复发缓解型 MS，严重依赖于生物疾病修正疗法（DMTs）。然而，目前的治疗费用对患者来说是一个巨大的障碍。在未来几年，用于 MS 的关键生物药物的专有权期可能会结束，为生物类似药进入市场打开大门。
在这篇综述中，我们讨论了什么是生物类似药，以及在多个治疗领域的现有生物类似药经验如何为欧洲和美国的 MS 治疗领域引入生物类似药提供信息。
目前，人们对小分子、非生物复杂药物和生物药物之间的区别和相似之处，以及不同类别的后续药物缺乏了解和认识。这些药物包括与参照生物制剂具有相同疗效和安全性的生物类似药。了解和认识生物类似药等药物类别所需的严格审批途径是建立对治疗结果的信心的关键。例如，生物类似药有时仅被视为其参照生物制剂的“复制品”，尽管它们经历了一个严格的审批过程，要求在生物类似药和参照药物之间观察不到任何具有临床意义的差异。对于 MS，未来引入生物类似药将使更多的 MS 患者能够接受有效治疗，也将扩大 MS 患者对生物 DMT 的使用。在多个治疗领域使用生物类似药的经验告诉我们，这可以为医疗保健系统节省成本。在其他治疗领域引入生物类似药也表明，为了成功将生物类似药整合到临床实践中，适当、准确的教育和信息是非常重要的。
为了在未来几年实现 MS 的优化治疗结果，并为生物类似药在不断变化的 MS 领域找到合适的位置，临床医生和 MS 患者必须了解生物类似药的基础知识，了解它们的潜在益处以及生物类似药提供的治疗一致性，因为其与参照药物具有相同的疗效和安全性。正如其他治疗领域所证明的那样，生物类似药可以通过提供一种具有成本效益的替代方案来减轻 MS 治疗武器库的关键获取障碍，同时提供与参照生物制剂相同的治疗效果。
