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Biosimilars: The paradox of sharing the same pharmacological action without full chemical identity

机译：生物仿制药：在没有完全化学同一性的情况下共享相同药理作用的悖论

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摘要

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.
机译：生物技术药物的使用正在增加，因此增加了国家卫生系统（NHS）的费用。应将生物仿制药视为改善获得医疗服务的机会。另一方面，公众可能会怀疑收到劣质药品以省钱。实际上，相对于现有替代品而言，药品质量较低的药品都不能以较低的价格获得授权。仅当生物仿制药的质量与原始仿制药的质量相同时，才可以授权。生物仿制药与始发者之间没有化学同一性：必须证明质量属性上的任何差异，并通过包括预批准的非临床和/或临床研究在内的科学调查表明，其不影响生物仿制药的安全性和有效性。生物仿制药的安全性概况可能与原始产品不同，也可能随着时间的推移而变化。因此，限制生物仿制药广泛使用的警告仍然存在，应通过对生物技术药物的主要生物学问题进行教育，并不断更新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来解决。

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