生物仿制药综述——一种从生命出发、为生命而生的药物

Dnyanda Kangude, S. Mankar
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引用次数: 0

摘要

在结构和功能上与生物药物非常接近的药物。生物药物是由蛋白质或蛋白质片段制成的药物。它们与其他药物天然或人为地不同。生物药物必须在酵母、细菌或动物细胞等生命系统中,利用生物技术工具进行生产。作为药物,生物制剂比小分子制剂有许多优点。生物制剂具有很强的靶向性,其副作用多与夸大的药理作用有关。而小分子更容易诱发有害的非靶效应。制造生物制剂包括对细胞进行基因修饰,这成为用于生产生物药物所需蛋白质的细胞系的基础。根据评估报告,到2022年,生物仿制药的制药使用将占顶级制药销售额的50%。生物仿制药是根据其安全性、质量和有效性获得批准的,适用于所有生物药物。生物仿制药与生物药物高度相似。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Review on Biosimilar – A Medicine from the Life and for the Life
The medicine that is very close in structure and function to biological drugs. Biological drugs are the drugs made from proteins or are piece of proteins. They are naturally or artificially unlike other drugs. Biological drug must be made in living system like yeast, bacteria or animal cells using biotechnology tools. As drug, biologic have several advantages over small molecule. Biologics are very target – specific and their side – effects are mostly related to exaggerated pharmacological effect. Whereas small molecule are more prone to induce harmful non - target effect. Manufacturing a biologic consist of genetically modifying a cell, which become the basis for a cell line used for the production of the necessary protein for biologic medicine. As per the evaluated report of pharm use of biosimilar contributing to 50% of top pharma sales by 2022. Biosimilar are approved according to their safety, quality and efficacy which is apply to all biological medicine. Biosimilar are highly similar to biological medicine.
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