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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

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

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介绍仿制药,仿制药更加便宜并且易于购买。

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