After two decades of experience with biosimilars, physicochemical and in vitro biological comparison with their reference products appear sufficient to guarantee clinical safety and efficacy. Hence, the regulation of biosimilars has become redundant, and biopharmaceuticals should now be regulated through the generic pathway available for small molecules.

中文翻译：

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生物仿制药法规的下放


经过二十年的生物仿制药经验，与其参比产品的物理化学和体外生物学比较似乎足以保证临床安全性和有效性。因此，生物仿制药的监管变得多余，生物制药现在应该通过可用于小分子的通用途径进行监管。