Non-Biological Complex Drugs, Vifor Pharma Ltd., Glattbrugg, Switzerland.
School of Pharmaceutical Sciences, University of Geneva - University of Lausanne, Geneva, Switzerland.
Eur J Pharm Sci. 2019 Feb 1;128:73-80. doi: 10.1016/j.ejps.2018.11.019. Epub 2018 Nov 20.
Nanomedicines, since the approval of the first one in the 1950s, have been accompanied by expectations of higher efficiency and efficacy, compared to less complex drugs. The fulfilment of those expectations has been slower than anticipated, due to the high complexity of nanomedicine drugs combined with a lack of scientific understanding of nanomedicine interactions with biological systems. The unique properties of their size and their surface composition create difficulties in their physicochemical characterization, and as a consequence, difficulty in assessing the similarity of follow-on products (nanosimilars) to originator nanomedicines. During the 2018 European Federation for Pharmaceutical Sciences (EUFEPS) annual meeting "Crossing the barrier for future medicines" in Athens, there were several sessions on nanomedicines organised by the EUFEPS Nanomedicine Network. This review focuses on the session "Nanomedicines and nanosimilars: how to assess similar?", discussing the nature of nanomedicines, the regulatory aspects of the topic and the impact of practical use and handling of such medicinal products. Emphasis is put on the consequences their nanosize-related properties have on the establishment of their critical quality attributes and how this affects the demonstration of bioequivalence of nanosimilars to their originator products. The lack of an appropriate and harmonized regulatory evaluation procedure and the absence of corresponding education are also discussed, especially the uncertainty surrounding the practical use of nanosimilars, including the higher healthcare cost due to less than satisfactory number of safe and efficacious nanosimilars in the market.
自 20 世纪 50 年代批准第一种纳米药物以来，与不太复杂的药物相比，人们一直期望纳米药物具有更高的效率和疗效。由于纳米药物的高度复杂性以及对纳米药物与生物系统相互作用的科学认识不足，这些期望的实现速度比预期的要慢。其大小和表面组成的独特特性给它们的理化特性描述带来了困难，因此，评估后续产品（纳米类似物）与原创纳米药物的相似性变得困难。在 2018 年雅典举行的欧洲制药科学联合会（EUFEPS）年会上，EUFEPS 纳米医学网络组织了几次关于纳米医学的会议。这篇综述重点介绍了“未来药物的突破：纳米医学和纳米类似物——如何评估相似性？”这一会议，讨论了纳米医学的性质、该主题的监管方面以及此类药物的实际使用和处理的影响。重点是纳米尺寸相关特性对其关键质量属性的建立的影响，以及这如何影响纳米类似物与其原创产品的生物等效性的证明。还讨论了缺乏适当和协调的监管评估程序以及缺乏相应教育的问题，特别是由于市场上安全有效的纳米类似物数量不足，对纳米类似物的实际使用存在不确定性，包括医疗保健成本增加。
