Abstract：
Unfounded skepticism relating to biosimilars, arising from the assertion that they are not molecularly identical to their original counterpart, fails to acknowledge that no biological medicine, including Gonal-f® (from Merck Serono) is identical to itself. Molecular differences between the biosimilar and the reference medicines are irrelevant and clinically undetectable as long as they are contained within the accepted variability for the original medicine. Accordingly, the minor differences in \'ongoing pregnancy rate\' and \'live birth\' rate reported in a recent meta-analysis of biosimilars of Gonal-f® from Chua et al. are probably driven by product-unrelated factors, notwithstanding the fact that of the four products under analysis, only Ovaleap® (from Theramex UK Ltd) and Bemfola® (from Gedeon Richter Plc) can unambiguously be considered to be biosimilars. The EU Biosimilars model has proven successful, but some healthcare professionals, building on highly arguable premises, voice a distrust in biosimilars. Only if such scientifically unfounded distrust is reverted, the full promise of rFSH alfa biosimilars for reproductive medicine patients is likely to be fulfilled.
摘要：
关于生物仿制药的毫无根据的怀疑主义，由于断言它们在分子上与原始对应物不同，没有承认没有生物医学，包括Gonal-f®（来自MerckSerono）与自身相同。生物仿制药和参考药物之间的分子差异是不相关的，并且临床上无法检测到，只要它们包含在原始药物的公认变异性内即可。因此，Chua等人最近对Gonal-f®生物仿制药的荟萃分析报告的“持续妊娠率”和“活产率”的微小差异。可能是由与产品无关的因素驱动的，尽管在分析的四种产品中，只有Ovaleap®（来自TheramexUKLtd）和Bemfola®（来自GedeonRichterPlc）可以明确地被视为生物仿制药。欧盟生物仿制药模型已被证明是成功的，但是一些医疗保健专业人员，建筑在极具争议的场所，对生物仿制药的不信任.只有当这种科学上毫无根据的不信任被扭转时，rFSHα生物仿制药对生殖医学患者的全部承诺很可能实现。
