Niazi Sarfaraz K
College of Pharmacy, University of Illinois, Chicago, IL 60612, USA.
Pharmaceuticals (Basel). 2025 May 23;18(6):779. doi: 10.3390/ph18060779.
This detailed review looks at how the rules for proving biosimilarity are changing, mainly focusing on the requirements for comparative efficacy studies (CESs). As analytical technologies progress, mounting evidence suggests that when we establish robust analytical similarity and pharmacokinetic equivalence, CESs become less valuable. This review combines findings from over 600 studies on biosimilars found in PubMed (showing that no biosimilar with proven analytical similarity has ever failed a CES), looks at the differences in global regulations on this topic, and explains how the Food and Drug Administration's pharmacokinetic testing rules for biosimilars are similar to the bioequivalence testing for generics. Finally, specific changes to the Biologics Price Competition and Innovation Act (BPCIA) are suggested to make US rules match the growing global scientific agreement, which could lower development costs and speed up patient access to biosimilars while still keeping safety and effectiveness intact.
这篇详细的综述探讨了证明生物相似性的规则是如何变化的，主要聚焦于比较疗效研究（CESs）的要求。随着分析技术的进步，越来越多的证据表明，当我们建立起稳健的分析相似性和药代动力学等效性时，比较疗效研究的价值就会降低。这篇综述整合了从PubMed上找到的600多项关于生物类似药的研究结果（表明没有一种经证实具有分析相似性的生物类似药在比较疗效研究中失败过），审视了全球在这一主题上的法规差异，并解释了美国食品药品监督管理局针对生物类似药的药代动力学测试规则与仿制药的生物等效性测试规则有何相似之处。最后，文章建议对《生物制品价格竞争与创新法案》（BPCIA）进行具体修改，以使美国的规则与全球日益增长的科学共识相匹配，这有望降低研发成本，加快患者获得生物类似药的速度，同时仍能确保安全性和有效性不受影响。
