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何为生物仿制药 – 译学馆
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何为生物仿制药

Biosimilars: complex copycat drugs

Drugs come in different sizes –
每款药物的结构都不同
from small simple molecules like aspirin,
从结构简单的小分子药物如阿司匹林
to giant, complex biological drugs like monoclonal antibodies.
到结构复杂的大分子生物药如单克隆抗体类药
In recent years,
近年
biological drugs – or biologics – have revolutionised treatments
生物制药 也可以说是生物制剂
for cancers, metabolic diseases and inflammatory disorders.
彻底改变了癌症 代谢病和炎性病变的治疗方法
In 2016, roughly a quarter of all global drug sales were biologics.
2016年 全球售出的药品中约有四分之一是生物制剂类
But there’s a problem.
但这也存在一个问题
These drugs are incredibly difficult and time-consuming to make,
生物制剂类药品很难生产并且要花费大量时间
so they’re often prohibitively expensive.
因此价格常常十分昂贵
That may be about to change.
但这一情况或许将会有所改观
The patents on many biologics will soon expire,
大部分生物制剂的专利即将过期
which means that competitors
这意味着竞争者们
can try to make cheaper copycat versions called biosimilars.
可以试着做更便宜的仿制类药物即仿制药
Making a generic version of a small-molecule drug isn’t too difficult.
生产较为普通小分子药物并不太难
Chemists can reverse-engineer the structure
药物研发人员可以使用逆向工程重构分子结构
and use familiar synthesis techniques to create an exact copy.
并利用与之分子结构相近的合成技术制造一个完美的副本
But biologics are much more challenging.
但生物制剂非常具有挑战性
Making an exact copy is impossible
想做一个完美的副本几乎不可能
because of their size and complexity,
因为它们的分子结构和复杂性
and the original manufacturers have no
而且药物开发者也不会傻到
incentive to share their assembly plan,
公开他们的药物工艺流程
so the biosimilar developers have to start from scratch. First,
所以仿制药研发者们只能雾里看花
developers need to reproduce the basic structure as best they can,
研发人员需要仔细分析大量的药物和发布的数据
based on careful analysis of batches of products and published data.
尽可能的重构药物原基本结构
Then they need to replicate the three-dimensional drug with functional parts.
然后再复制出具有药用功能的立体分子结构
This is such a complex process that scientists rely on cultures
这一步过程非常复杂
of living cells to assemble the drug for them.
科学家们依靠培养出的活细胞聚合药物
By ceding control to this black-box system of living cells,
通过控制黑盒子系统里培养的细胞变量
the exact synthesis pathway remains hidden and is impossible to fully control.
准确的合成路径始终是个谜并且不可能完全控制
Another issue is that small differences in these live cultures,
另一个问题是活细胞培养变量
like temperature, pH, nutrients and so on,
像温度 酸碱度 营养物等
can cause chemical modifications which can affect the biologics’ function and safety.
都能造成化学变化影响生物制剂的功能和安全性
So the team must experiment to find the right conditions to make the drug in their own lab.
研发团队就必须进行实验 找出正确的条件以能够自行生产药物
Once it’s been made, the new drug must undergo stringent tests
一旦完成制药 新药一定要经过严苛检验
to check that its chemistry and function are similar to the originator drug.
以检查化学性质和功能与原药是否相似
For example, it needs to undergo functional tests
例如需要经过功能测试
to make sure it binds to its target.
确保药物能进行靶向结合
Then the new drug needs to
接着新药需要
be compared to the originator drug in clinical trials
进行临床实验与原药做对比
to make sure it works as well as its predecessor
确保与原药功效相近
and doesn’t set off an immune reaction
并且不会引起免疫反应
or have any other unexpected effects in the body.
或是产生其他没发现过的不良反应
No biosimilar will ever be identical to the originator drug,
没有一款生物仿制药能与原药完全相同
but modest chemical differences are acceptable
但存在部分的化学差异是可接受的
if the drug passes these rigorous tests in clinical trials.
如果药物通过严格药检和临床试验
This whole process can take more than ten years,
但这整个过程需要耗费十年以上
but it’s an effort worth making
不过却值得付出这么多努力
if it means that some blockbuster biologic drugs
如果能让一些出名的生物制剂
become more affordable and accessible for patients in the coming years.
在未来几年变得让病人更容易负担和获取
Some say that biosimilars could reduce global healthcare spending
生物仿制类药能减少未来五年
by US$160 billion over the next five years.
全球1600亿美元的医疗花费

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视频概述

介绍仿制药,仿制药更加便宜并且易于购买。

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视频来源

https://www.youtube.com/watch?v=XHdZAdYNLsc

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