Baker John, Kalb Robert
Dermatology Department, University at Buffalo, Buffalo, NY, USA.
J Psoriasis Psoriatic Arthritis. 2024 Jan;9(1):28-35. doi: 10.1177/24755303231212154. Epub 2023 Nov 3.
Safe and effective biosimilar medications have the potential to significantly increase access to these valuable drugs. The two current biosimilars available in dermatology in the United States (US) are infliximab and rituximab which were Food and Drug Administration (FDA) approved in 2016 and 2018 respectively. There has been significant interest in this topic as a number of biosimilar versions of adalimumab will be available in 2023.
This review will discuss biosimilar basics and the experience with biosimilars used in dermatology in the US, Asia, and Europe.
All articles in Ovid/Medline from 2015 to Feb 2023 on biosimilars were reviewed with a particular emphasis on medications used in dermatology. Other reports from pharmaceutical manufacturers and blogs following the development of the biosimilar industry provided key insights.
Biosimilars have been able to produce significant savings and market share increases, particularly in Europe, where there has been a longer experience. The specifics depend on drug prescribing practices and incentives in the individual country. This degree of savings and market share increases have not been realized with the current biosimilars available in the US.
While biosimilars have resulted in significant savings compared to originator drugs, it is clear that prescribing incentives and physician education are crucial in achieving these savings. To what degree biosimilar market share will increase in the US remains to be determined.
安全有效的生物类似药有潜力显著增加这些珍贵药物的可及性。美国目前皮肤科可用的两种生物类似药是英夫利昔单抗和利妥昔单抗,它们分别于2016年和2018年获得美国食品药品监督管理局(FDA)批准。由于2023年将有多种阿达木单抗生物类似药上市,该话题受到了广泛关注。
本综述将讨论生物类似药的基本情况以及美国、亚洲和欧洲在皮肤科使用生物类似药的经验。
对2015年至2023年2月Ovid/Medline上所有关于生物类似药的文章进行了综述,特别关注皮肤科使用的药物。制药商的其他报告以及生物类似药行业发展相关的博客提供了关键见解。
生物类似药已能够大幅节省成本并增加市场份额,尤其是在经验更为丰富的欧洲。具体情况取决于各国的药物处方习惯和激励措施。美国目前可用的生物类似药尚未实现如此程度的成本节省和市场份额增长。
虽然与原研药相比,生物类似药已大幅节省成本,但显然处方激励措施和医生教育对于实现这些成本节省至关重要。生物类似药在美国的市场份额将增加到何种程度仍有待确定。