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首页> 外文期刊>Drug Design, Development and Therapy >A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade ? )
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A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade ? )

机译：对美国监管途径的批判性审查，用于确定CT-P13和原始英夫利昔单抗（Remicade）之间的疗效等同性

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We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.
机译：我们在Planetra临床试验中评估了CT-P13的各种等效边距的适当性，incriximab生物蛋白酶。通过在系统文献搜索中统计，95-95％的方法用于独立地确定当历史临床试验与安慰剂的历史临床试验，以系统文献搜索确定。针对每个确定的历史临床审判评估了Planetra试验的恒定假设，以确定哪些研究是科学奠定基础。对每个研究汇总方案进行敏感性分析。因此，我们确定了两个被认为适当的历史临床试验，而Planetra试验汇总了三项额外研究以确定对等当量保证金，该研究是由美国食品和药物管理局所接受的。然而，这些额外的临床试验并未符合基线特征，甲氨蝶呤剂量和功效评估时间的恒定假设。临床上更合适的等价余量为5.7个百分点，比CT-P13批准所适用的12个百分点要窄得多。总之，当严格评估恒定假设时，对类风湿性关节炎患者的CT-P13对原始英夫利昔单抗的等价性要求似乎没有得到支持。生物仿制物的等效余量可以更保守地确定。

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