f*********e
发帖数: 1144 | 1 can somebody pls share thoughts on building biosimilar in China? It's not
looking good for biosimilar in US, how about the industry in China?
1. do they need to do clinical trial again in China? Ph1-Ph3? same patient
scale as in the states? how to evaluate clinical data comparability to
branded ones...
2. which local companies (Wuxi pharm?)have the capacity for manufacturing
and conducting related CQA tests? full cGMP compliance to which std?
3. Chinese FDA will invest the manufacturing and/or accelerate the approval
for local companies? And as a result, say would generic Herceptin beat the
sales of Herceptin in China?
curious about all these recently :) | O***O
发帖数: 264 | 2 1.属注册分类1和2的，应当进行临床试验。
（1）临床试验的病例数应当符合统计学要求和最低病例数要求；
（2）临床试验的最低病例数（试验组）要求：
I期为20至30例，II期为100例，III期为300例，IV期为2000例。
（3）避孕药的I期临床试验应当按照本办法的规定进行；II期临床试验应当完成至
少100对6个月经周期的随机对照试验；III期临床试验完成至少1000例12个月经周期的
开放试验；IV期临床试验应当充分考虑该类药品的可变因素，完成足够样本量的研究工
作。
2.属注册分类3和4的，应当进行人体药代动力学研究和至少100对随机对照临床试验。
多个适应症的，每个主要适应症的病例数不少于60对。避孕药应当进行人体药代动力学
研究和至少500例12个月经周期的开放试验。
属于下列二种情况的，可以免予进行人体药代动力学研究：
（1）局部用药，且仅发挥局部治疗作用的制剂；
（2）不吸收的口服制剂。
3.属注册分类5的，临床试验按照下列原则进行：
（1）口服固体制剂应当进行生物等效性试验，一般为18至24例；
（2）难以进行生物等效性试验的口服固体制剂及其他非口服固体制剂，应当进行
临床试验，临床试验的病例数至少为100对；
（3）缓释、控释制剂应当进行单次和多次给药的人体药代动力学的对比研究和必
要的治疗学相关的临床试验，临床试验的病例数至少为100对；
（4）注射剂应当进行必要的临床试验。需要进行临床试验的，单一活性成份注射
剂，临床试验的病例数至少为100对；多组份注射剂，临床试验的病例数至少为300例（
试验药）；脂质体、微球、微乳等注射剂，应根据注册分类1和2的要求进行临床试验。
4.对于注册分类6中的口服固体制剂，应当进行生物等效性试验，一般为18至24例。
需要用工艺和标准控制药品质量的，应当进行临床试验，临床试验的病例数至少为
100对。
approval
【在 f*********e 的大作中提到】
: can somebody pls share thoughts on building biosimilar in China? It's not
: looking good for biosimilar in US, how about the industry in China?
: 1. do they need to do clinical trial again in China? Ph1-Ph3? same patient
: scale as in the states? how to evaluate clinical data comparability to
: branded ones...
: 2. which local companies (Wuxi pharm?)have the capacity for manufacturing
: and conducting related CQA tests? full cGMP compliance to which std?
: 3. Chinese FDA will invest the manufacturing and/or accelerate the approval
: for local companies? And as a result, say would generic Herceptin beat the
: sales of Herceptin in China?
| l***d
发帖数: 1828 | 3 biosimilar在美国很差吗？我怎么感觉所有大药厂都在研究biosimilar,也许我不在药
厂吧，我知道比小分子难，尤其QC和formulation比较难，我还打算去ASMS看看大家怎
么检测biosimilar的 | b*******e
发帖数: 724 | 4 1。SFDA连怎么审查branded 大分子还没搞懂呢，更别说biosimilar了，
2。中信国建
3。who knows.中国药品的marketing 就是一潭混水。
★ 发自iPhone App: ChineseWeb 7.8
【在 f*********e 的大作中提到】
: can somebody pls share thoughts on building biosimilar in China? It's not
: looking good for biosimilar in US, how about the industry in China?
: 1. do they need to do clinical trial again in China? Ph1-Ph3? same patient
: scale as in the states? how to evaluate clinical data comparability to
: branded ones...
: 2. which local companies (Wuxi pharm?)have the capacity for manufacturing
: and conducting related CQA tests? full cGMP compliance to which std?
: 3. Chinese FDA will invest the manufacturing and/or accelerate the approval
: for local companies? And as a result, say would generic Herceptin beat the
: sales of Herceptin in China?
| k******n
发帖数: 133 | 5 中国的biosimilar一般会被认定为新药，要求独立完成临床。完全不需要和branded药
similar, thus, the barrier for entry is much lower than that of us and eu.
On the other hand, since you cant establish similarity/interchangeability,
you can't market it as the "generic" version of the branded one in developed
world.
SFDA has almost no expertise/experience dealing with biologics. Hopefully
things are changing in a few years.
Wuxi is working with AZ to establish biologics activity for new biologics,
not biosimilar.
I am pessmistic about most companies in biosimilar spaces Other than a
handful major players (amgen, BI, Merck), it's a club only for the big guys.
approval
【在 f*********e 的大作中提到】
: can somebody pls share thoughts on building biosimilar in China? It's not
: looking good for biosimilar in US, how about the industry in China?
: 1. do they need to do clinical trial again in China? Ph1-Ph3? same patient
: scale as in the states? how to evaluate clinical data comparability to
: branded ones...
: 2. which local companies (Wuxi pharm?)have the capacity for manufacturing
: and conducting related CQA tests? full cGMP compliance to which std?
: 3. Chinese FDA will invest the manufacturing and/or accelerate the approval
: for local companies? And as a result, say would generic Herceptin beat the
: sales of Herceptin in China?
| f*********e
发帖数: 1144 | 6
---have been doing some reading lately. you are exactly right. SFDA treats
whatever biologics as a new molecule, very actively help fund lots local
firm to reformulate mAb drugs, so called" green channel" :)
developed
---cGMP standard facility have been invested, maybe a sign SFDA is catching
up to set regulations on production
---biosimilar does not look good in the states, if you can't lower the cost
as small molecule generic drugs, not profitable at all.
The only place for "biosimilar" is prob in China, they call it "innovation",
just define it in a different way as "me too, but lower cost" :)
【在 k******n 的大作中提到】
: 中国的biosimilar一般会被认定为新药，要求独立完成临床。完全不需要和branded药
: similar, thus, the barrier for entry is much lower than that of us and eu.
: On the other hand, since you cant establish similarity/interchangeability,
: you can't market it as the "generic" version of the branded one in developed
: world.
: SFDA has almost no expertise/experience dealing with biologics. Hopefully
: things are changing in a few years.
: Wuxi is working with AZ to establish biologics activity for new biologics,
: not biosimilar.
: I am pessmistic about most companies in biosimilar spaces Other than a
| k******n
发帖数: 133 | 7 I disagree with your comments about biosimilar in US. The market is huge and
has a high entry barrier, which scares away all small players. As long as
you can make a "good" biosimilar, you can easily sell at 70% of the
originator's price and earn a decent profit. You can never sell them as
cheap as small generic drugs.
catching
cost
",
【在 f*********e 的大作中提到】
:
: ---have been doing some reading lately. you are exactly right. SFDA treats
: whatever biologics as a new molecule, very actively help fund lots local
: firm to reformulate mAb drugs, so called" green channel" :)
: developed
: ---cGMP standard facility have been invested, maybe a sign SFDA is catching
: up to set regulations on production
: ---biosimilar does not look good in the states, if you can't lower the cost
: as small molecule generic drugs, not profitable at all.
: The only place for "biosimilar" is prob in China, they call it "innovation",
| Y**p
发帖数: 45 | 8 No future on Biosimilar in the US. See Roche, example: GH.
[发表自未名空间手机版 - m.mitbbs.com] | k******n
发帖数: 133 | 9 Can you elaborate? I'd like to know more about your reasoning.
【在 Y**p 的大作中提到】
: No future on Biosimilar in the US. See Roche, example: GH.
: [发表自未名空间手机版 - m.mitbbs.com]
| j*****y
发帖数: 121 | 10 中国生物仿制药的领跑者有中信国健 上海赛金 嘉和生物等，大公司如海正，wuxi
pharma 。。。
中国的生物仿制药目前机会很好，政府大力扶持，但很明显，大部分创业公司都是为了
忽悠钱，能成功的少之又少，估计很多最后要破产或者被大公司并购。
细胞株大部分是从美国购买的。工艺开发是弱势，不过最近从美国大公司回国了一批人
，比如shun luo 等或许能带去一些大公司的核心技术。
质量控制方面，需要提供大量和原研药对比的资料，尤其是糖基化糖型等，怎么说服
sfda。 |
|
