a Rheumatology Clinic, Department of Internal Medicine, Medical School , University of Ioannina , Ioannina , Greece.
Expert Opin Biol Ther. 2019 Mar;19(3):173-179. doi: 10.1080/14712598.2019.1566456. Epub 2019 Jan 11.
Biosimilars are highly similar molecules to other biological medicines that have already been authorized for use. Etanercept (ETN) was the first anti-tumor necrosis factor inhibitor (TNFi) approved by the Food and Drug Administration for the treatment of moderate to severe rheumatoid arthritis (RA) in November 1998 and in February 2000 by the European Medicines Agency. Twenty years later, the first ETN biosimilar has come of age. Areas covered: In this review we examined SB-4 as a biosimilar candidate to ETN, focusing on the available data. Current data indicate that SB-4 is a highly similar alternative to ETN in terms of safety, efficacy, tolerability, and immunogenicity. SB-4 has already been approved by health authorities in Europe, South Korea, Australia, and Canada, as a subcutaneous therapy option for the treatment of patients with RA but also for the full spectrum approved for its bio-originator ETN. Expert opinion: The current body of evidence suggests that all biologic activities have been demonstrated to be equivalent between SB-4 and the originator, including pharmacodynamic and pharmacokinetic activities. In some areas, and more specifically when it comes to immunogenicity, SB-4 showed lower incidents. Therefore, it is fully expected to have same efficacy and safety in all indications.
生物类似药是与已获准使用的其他生物药物高度相似的分子。依那西普（ETN）是 1998 年 11 月美国食品和药物管理局（FDA）批准用于治疗中重度类风湿关节炎（RA）的首个抗肿瘤坏死因子抑制剂（TNFi），2000 年 2 月欧洲药品管理局（EMA）也批准了该药物。20 年后，首个 ETN 生物类似药应运而生。
在这篇综述中，我们将 SB-4 作为 ETN 的生物类似候选药物进行了研究，重点关注现有数据。现有数据表明，SB-4 在安全性、疗效、耐受性和免疫原性方面与 ETN 高度相似。SB-4 已在欧洲、韩国、澳大利亚和加拿大获得批准，可作为皮下治疗选择，用于治疗 RA 患者，但也可用于其生物原研药 ETN 批准的全谱治疗。
目前的证据表明，SB-4 与原研药在所有生物活性方面均等效，包括药效学和药代动力学活性。在某些方面，特别是在免疫原性方面，SB-4 显示出较低的发生率。因此，预计在所有适应证中均具有相同的疗效和安全性。
