The protein science of biosimilars
The protein science of biosimilars
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DOI：
10.1093/ndt/gfl474
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发表时间：
2006-10-01
影响因子：
6.1
通讯作者：
Covic, Adrian
中科院分区：
文献类型：
--
作者：
Kuhlmann, Martin;Covic, Adrian
非专利药品制造行业正在发生翻天覆地的变化，第一波生物技术衍生产品的专利寿命即将结束。然而，就分子复杂性而言，重组蛋白与其化学前身处于不同的级别。制造过程中的微小差异可能会影响重组蛋白质的有效性和安全性，而这种影响并不总是可以使用分析或体外技术来测量的。因此，具有可比性的临床特征并不能自动从物理化学相似性中得出结论，只能通过临床研究来证实。创新者和生物相似制造商通过在批次之间执行严格的纯度和活性分析，并实施量身定制的药物警戒计划，确保生产的一致性，这对患者安全至关重要。
A sea change is occurring in the off-patent drug manufacturing industry with a first wave of biotechnologically derived products reaching the end of their patent lives. However, recombinant proteins are in a different league from their chemical predecessors in terms of molecular complexity. Small differences in manufacturing processes can affect the efficacy and safety of the recombinant proteins in a manner which is not always measurable using analytical or in vitro techniques. Thus, comparable clinical profiles do not automatically follow from physicochemical likeness and can only be demonstrated through clinical studies. It is essential for patient safety that both innovator and biosimilar manufacturers ensure consistency in their production, by performing rigorous purity and activity profiling between batches, and implement tailored pharmacovigilance plans.