College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
Medical College of Georgia, Augusta University, Augusta, GA, USA.
Am J Clin Dermatol. 2020 Aug;21(4):483-491. doi: 10.1007/s40257-020-00507-1.
Biologic drugs have revolutionized the treatment of psoriasis and other chronic inflammatory diseases. In recent years, many tumor necrosis factor-alpha 'biosimilar' agents have been developed. These biosimilars are similar in structure and function to their originator molecules, although they are not identical. Given that the safety and efficacy of the original biologic have already been proven, biosimilars are only required to show bioequivalence, or non-inferiority, to the reference biologic to be approved. Based on extrapolation of these non-inferiority data, biosimilars may be subsequently approved for all indications of the originator biologic, even without being directly studied in these various conditions. These biosimilar agents have been purported as a method to reduce the costs of biologic therapies, thereby increasing the accessibility of these medications and subsequently improving the treatment of psoriasis worldwide. The US Food and Drug Administration and/or the European Medicines Agency have approved biosimilars of adalimumab (Amjevita/Amgevita/Solymbic, Cyltezo, Imraldi/Hadlima, Hyrimoz/Hefiya/Halimatoz, Idacio, Hulio, Abrilada), etanercept (Erelzi, Benepali/Eticovo), and infliximab (Inflectra/Remsima, Renflexis/Flixabi, Ixifi/Zessly) for the treatment of psoriasis, and others are under review. There are many phase III data supporting the bioequivalence of these anti-tumor necrosis factor-alpha biosimilar agents in treating psoriasis and rheumatologic disease, which are discussed here. In general, these biosimilar agents have been shown to have equivalent efficacy, tolerability, and immunogenicity profiles compared to their originators in patients with rheumatologic disease, although studies in patients with psoriasis are fairly limited. Additional switching studies and post-marketing safety analyses are needed to assess the interchangeability of biosimilar agents with their reference products.
生物制剂已经彻底改变了银屑病和其他慢性炎症性疾病的治疗方式。近年来，已经开发出许多肿瘤坏死因子-α“生物类似药”。这些生物类似药在结构和功能上与它们的原创分子相似，尽管它们并不完全相同。由于原始生物制剂的安全性和有效性已经得到证实，生物类似药只需证明与参比生物制剂具有生物等效性（即非劣效性）即可获得批准。基于这些非劣效性数据的推断，生物类似药随后可能被批准用于原始生物制剂的所有适应证，即使它们没有在这些各种情况下直接进行研究。这些生物类似药据称是降低生物治疗成本的一种方法，从而增加这些药物的可及性，并随后改善全球银屑病的治疗效果。美国食品和药物管理局（FDA）和/或欧洲药品管理局（EMA）已经批准了阿达木单抗（Amjevita/Amgevita/Solymbic、Cyltezo、Imraldi/Hadlima、Hyrimoz/Hefiya/Halimatoz、Idacio、Hulio、Abrilada）、依那西普（Erelzi、Benepali/Eticovo）和英夫利昔单抗（Inflectra/Remsima、Renflexis/Flixabi、Ixifi/Zessly）的生物类似药用于治疗银屑病，其他药物正在审查中。有许多 III 期数据支持这些抗肿瘤坏死因子-α生物类似药在治疗银屑病和风湿性疾病方面的生物等效性，本文对此进行了讨论。一般来说，这些生物类似药在风湿性疾病患者中与原创药相比，具有等效的疗效、耐受性和免疫原性特征，尽管针对银屑病患者的研究相当有限。需要进一步的转换研究和上市后安全性分析来评估生物类似药与其参比产品的可互换性。
