Italian Medicines Agency , Via del Tritone, 181, 00187, Rome , Italy
Expert Opin Biol Ther. 2013 Oct;13(10):1343-6. doi: 10.1517/14712598.2013.815722. Epub 2013 Jun 28.
The use of biotech medicines is increasing, with consequent mounting expenses for National Health Systems (NHSs). Biosimilars should be considered an opportunity to improve access to care. On the other side, the general public might suspect to receive low-quality medicines to save money. Actually, no drugs with a lesser degree of pharmaceutical quality with respect to existing alternatives can be authorized on the ground of a lower price. Biosimilars can be authorized only if their quality is of the same level as that of the originator. There is no chemical identity between biosimilars and the originators: any differences in quality attributes must be justified and shown not to impact on the safety and efficacy of the biosimilar by scientific investigations including pre-approval nonclinical and/or clinical studies. The biosimilar safety profile may be different from the originator or change over time for the same product. Hence caveats limiting the widespread use of biosimilars yet exist and should be solved by education on the main biological issues of biotech medicines, and on continuous update of the rules set up by the Regulatory Authorities to assess biosimilarity and to monitor post-approval safety.
生物类似药的使用正在增加，随之而来的是国家卫生系统（NHS）的费用不断增加。生物类似药应该被视为改善医疗服务可及性的机会。另一方面，公众可能会怀疑为了省钱而使用低质量的药物。实际上，不能仅仅因为价格较低，就批准药品质量低于现有替代品的药物。只有当生物类似药的质量与原研药相当时，才能获得批准。生物类似药与原研药之间没有化学上的一致性：任何质量属性的差异都必须得到证明，并且通过包括预批准的非临床和/或临床研究在内的科学研究表明不会影响生物类似药的安全性和疗效。生物类似药的安全性概况可能与原研药不同，或者同一产品的安全性概况随时间而变化。因此，限制生物类似药广泛使用的警告仍然存在，应该通过教育来解决，内容涉及生物技术药物的主要生物学问题，以及对监管机构制定的评估生物相似性和监测批准后安全性的规则进行持续更新。
