Institute of Medical Sciences, Tzu Chi University, Hualien, Taiwan.
Stat Med. 2013 Feb 10;32(3):406-14. doi: 10.1002/sim.5570. Epub 2012 Aug 17.
Unlike small molecule drug products, biological products are therapeutic agents producted using of a living system or organism. Thus, the development of biologic products is a very different and complicated process that is sensitive to environmental factors such as light and temperature. Therefore, the therapeutic effect of follow-on biologic products may not be equivalent to the innovative products even though the average biosimilarity has been established. Thus, Chow et al. suggested that the assessment of biosimilarity between biologic products should be conducted on the basis of variability in 2010. In this article, we propose a biosimilar index that is derived on the basis of estimated reproducibility probability approach and Bayesian approach, respectively. We conducted simulation studies to empirically investigate the relationship of reproducibility probability under various parameter combinations. The simulation results demonstrate that the proposed method based on biosimilar index can reflect the characteristics and impact of variability on the therapeutic effect of biologic products.
与小分子药物产品不同，生物制品是使用活系统或生物体生产的治疗剂。因此，生物制品的开发是一个非常不同和复杂的过程，容易受到环境因素（如光和温度）的影响。因此，即使已经建立了平均生物相似性，后续生物制品的治疗效果也可能与创新产品不同。因此，Chow 等人建议，应根据 2010 年的变异性来评估生物制品之间的生物相似性。在本文中，我们分别基于可再现性概率估计方法和贝叶斯方法提出了一个生物相似性指数。我们进行了模拟研究，以经验性地研究在各种参数组合下可再现性概率的关系。模拟结果表明，基于生物相似性指数的方法可以反映生物制品治疗效果的变异性特征和影响。
