Courage Noel, Parsons Ainslie
Bereskin & Parr LLP, Toronto, Canada.
Food Drug Law J. 2011;66(2):203-24, i-ii.
A biosimilar contains an active ingredient that is similar, but not identical, to the active ingredient in an approved reference drug. This raises the issue of when and how a biosimilar should be allowed to compare to a reference drug for marketing approval. This paper looks at the current regulation of biosimilars in Europe, the United States and Canada. The response to the challenge of regulating biosimilars has been varied. For example, Europe implemented a specialized, abbreviated legal pathway about five years before the United States. In Canada, abbreviated approval by comparison to an approved reference biologic was already available under the existing regulatory framework. Regulators have significant discretion to set criteria establishing when a biosimilar is deemed comparable to a reference biologic. The comparability standards for review of the one biosimilar approved in all three jurisdictions (Omnitrope, a human growth hormone) were largely consistent. Omnitrope may be instructive as to the potential standard of review for future single chain protein biosimilars. In contrast, the United States approved a second-entry low molecular weight heparin with no clinical trials, whereas European guidelines state that clinical trial data will be required.
生物类似药所含活性成分与已获批参比药物中的活性成分相似但不完全相同。这就引发了一个问题，即何时以及如何允许生物类似药与参比药物进行对比以获得上市批准。本文探讨了欧洲、美国和加拿大目前对生物类似药的监管情况。对监管生物类似药这一挑战的应对方式各不相同。例如，欧洲比美国早约五年实施了一条专门的简化法律途径。在加拿大，根据现有的监管框架，与已获批参比生物制品对比进行简化批准已然可行。监管机构在确定生物类似药何时被视为可与参比生物制品可比的标准方面拥有很大的自由裁量权。在所有三个司法管辖区均获批的一种生物类似药（Omnitrope，一种人生长激素）的审评可比标准在很大程度上是一致的。Omnitrope对于未来单链蛋白质生物类似药的潜在审评标准可能具有指导意义。相比之下，美国批准了一种无需进行临床试验的第二代低分子量肝素，而欧洲指南则指出将需要临床试验数据。
