Fortis Flt. Lt. Rajan Dhall Hospital, Department of Diabetes and Metabolic Diseases, Vasant Kunj, New Delhi 110070, India.
Expert Opin Biol Ther. 2010 Apr;10(4):489-94. doi: 10.1517/14712591003662615.
Ever since the formation of the first biotechnology company almost three decades ago, more than 150 biopharmaceutical products have been marketed across the globe. The oldest of these biotechnology-derived products are now at the end of their patent lives, as a result of which, the development of 'biosimilars' is increasing.
The review highlights aspects in which biosimilars differ from generic drugs.
The active substance of a biosimilar medicine is similar to the one of the biological reference medicine; however, biosimilars differ from generics of pharmacological drugs in aspects like size and complexity of the active substance, and the nature of the manufacturing process. The manufacture of a biopharmaceutical product is complex and involves several isolation and purification steps. These procedures are proprietary to the manufacturer of the originator product and hence even minor changes in production can have serious implications in terms of safety and efficacy of the product.
Biosimilars should not be brought to market using the same procedure applied to generics, and existing and future regulation should prevent inappropriate and automatic substitution of a biosimilar for a reference biopharmaceutical product.
自大约三十年前第一家生物技术公司成立以来，已有超过 150 种生物制药产品在全球上市。这些生物技术衍生产品中最古老的产品现在已经过了专利期，因此“生物类似药”的开发正在增加。
该综述强调了生物类似药与仿制药的不同之处。
生物类似药药物的活性物质与生物参考药物的活性物质相似；然而，生物类似药与药理学药物的仿制药在活性物质的大小和复杂性以及制造工艺的性质等方面存在差异。生物制药产品的制造非常复杂，涉及多个分离和纯化步骤。这些程序是原创产品制造商专有的，因此即使生产中的微小变化也会对产品的安全性和疗效产生严重影响。
不应使用适用于仿制药的相同程序将生物类似药推向市场，现有的和未来的法规应防止将生物类似药不适当地和自动替代参考生物制药产品。
