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BioDrugs. 2017 Oct;31(5):461-464. doi: 10.1007/s40259-017-0240-7.
SB2 is a biosimilar of the reference anti-TNF-α antibody infliximab. In May 2015, it was approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is also approved in these indications in several other countries, including Korea, the USA and Australia. Characterization of SB2 in preclinical studies showed that it is similar to reference infliximab. SB2 demonstrated pharmacokinetic biosimilarity to reference infliximab in healthy volunteers, and clinically equivalent efficacy in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. SB2 was generally well tolerated; the safety and immunogenicity profiles were similar to those of reference infliximab with no additional safety concerns identified. Switching from reference infliximab to SB2 did not impact clinical efficacy, safety or immunogenicity. The role of reference infliximab in the management of autoimmune inflammatory conditions is well established, and SB2 provides an effective biosimilar alternative for patients requiring infliximab therapy.
SB2 是一种与参考抗 TNF-α 抗体英夫利昔单抗生物类似的药物。2015 年 5 月，它在欧盟获得批准，可用于参考英夫利昔单抗批准的所有适应证，包括类风湿关节炎、强直性脊柱炎、克罗恩病、溃疡性结肠炎、银屑病关节炎和银屑病。它在包括韩国、美国和澳大利亚在内的其他几个国家也批准用于这些适应证。在临床前研究中对 SB2 的特征描述表明，它与参考英夫利昔单抗相似。SB2 在健康志愿者中的药代动力学具有生物类似性，与接受甲氨蝶呤治疗的中重度类风湿关节炎患者的临床等效疗效。SB2 总体耐受性良好；安全性和免疫原性特征与参考英夫利昔单抗相似，未发现其他安全性问题。从参考英夫利昔单抗转换为 SB2 不会影响临床疗效、安全性或免疫原性。参考英夫利昔单抗在治疗自身免疫性炎症性疾病中的作用已得到充分确立，SB2 为需要英夫利昔单抗治疗的患者提供了有效的生物类似药物替代方案。
