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究竟谁真正通过了一致性评价?送你一面药交会“照妖镜”!

魔方君 魔方君 来源:医药魔方
2018-12-04
一致性评价
原文

第80届药交会将于明日在广州拉开序幕,作为医药行业里的一大盛会,约2000家药企纷纷寄希望于借此机会招商宣介,扩大销售渠道与企业影响力。而在一致性评价、医保、4+7等官方政策频出的2018年,一致性评价品种无疑是参会代理商关注的焦点。


据医药魔方PharmaGO数据监测,目前通过一致性评价的品种(按厂家区分)有87个,参加了本次药交会的有30个,占比34%,可谓凤毛麟角。


如何快速找到这些品种在哪个展位呢?为此,我们特别做了一款小程序【药交会助手】,可以查品种、查企业,一步锁定品种所在展位。重要的是,查询是免费的,堪称业界良心出品。


选中的品种,添加关注,即可以“我的关注”中随时翻看,一家一家走下来,广州之行就任务完成,有木有?!



在此也提醒诸位,一定要擦亮眼睛,不要被厂家的宣传所蒙蔽。随便到药交会转一圈,你会发现“一致性评价”品种居然遍地开花。比如下面这种,实在是令人目瞪口呆。



他达拉非片、拉米夫定片、左氧氟沙星片、伏立康唑片、盐酸美金刚片这些品种,国内尚无一家通过评价,您这是谁给通过的呢?


再扫一眼“即将通过一致性评价”的品种,一水是注射剂,更是让人震惊。可以明确地告诉你,目前申请一致性评价的注射剂,基本全军覆没,企业纷纷主动撤回。


据我们监测,不过只有普利制药的注射用阿奇霉素,通过国内外共线,真正通过了一致性评价。普利的展位在9.2J08,有兴趣的可以去聊聊。



这些厂家号称自己的品种通过了一致性评价,主要无非是下面两种由头:


1、已经在国外上市,国内视同通过一致性评价。


这一条比较唬人的。但我可以明确地说,已在国外上市并不等于国内一定会通过一致性评价。一看国外上市地区,是否为欧美日;二看国内外是否为同一生产线生产;三看国内外的组方工艺是否一致,可能原辅料完全不同。


况且,但凡已经在国内申报的,CDE都会给予优先审评,并且标出国内外共线。没被CDE披露过的,还是算了吧。


CDE这几年总共公布了63个国内外共线品种,但批准出来的也就5个而已。您家的品种真的是这1/12吗?


2、做BE了,马上就报上去了。


据医药魔方PharmaGO数据监测,自2015年临床试验数据核查以来,国内申请的BE试验数量为1996个。其中,已完成BE的1042个,主动暂停46个,正在和刚完成患者招募的908个。看起来好像BE成功率挺高,但千万要注意,完成不代表通过,失败也是完成的状态。岂不知,这里面有多少失败的呢?


我们以氨氯地平为例,按品种及厂家计数,已完成BE试验32个,但申报到CDE的仅19个。其他13个品种咋还不报呢?为啥呢?我们估且算个粗账,可以理解为约40%的BE试验结果可能并不乐观。


所以我们看到步长今天的公告,委托CRO开发注射用伏立康唑,愿意付出1500万代价,只求能包过。

机器翻译

The 80th Pharmaceutical Fair will kick off tomorrow in Guangzhou. As a major event in the pharmaceutical industry, about 2,000 pharmaceutical companies have hoped to take this opportunity to promote investment and expand their sales channels and corporate influence.In 2018, when the official policies such as conformity assessment, medical insurance, and 4 + 7 are frequent, the variety of conformity assessment is undoubtedly the focus of the participating agents.

According to the medical Rubik's Cube PharmaGO data monitoring, there are currently 87 varieties that have passed the conformity assessment (according to the manufacturer's distinction), and 30 have participated in this drug fair, accounting for 34%, which is rare.

How to quickly find which stand these varieties are in?To this end, we specially made a small program [assistant to the drug fair], you can check the variety, check the company, one step lock the variety booth.The important thing is that the inquiry is free and can be called the conscientious production of the industry.

Selected varieties, add attention, that is, you can "my attention" at any time to look at, one by one, the trip to Guangzhou on the task, there is wood?!

Also remind you here, be sure to keep your eyes open and not be blinded by the manufacturer's propaganda.If you go around the drug fair, you will find that the "conformity assessment" variety actually blossoms.For example, the following is really stunning.

Tadalafil tablets, lamivudine tablets, levofloxacin tablets, voriconazole tablets, and memantine hydrochloride tablets have not been evaluated in China. Who did you pass this?

The variety that "is about to pass the conformity assessment" is even more shocking.You can clearly tell that the current application for consistency assessment of injections, basically completely annihilated, companies have taken the initiative to withdraw.

According to our monitoring, only Puli Pharmaceutical's azithromycin for injection has passed the conformity assessment through domestic and foreign collinearity.Puli's booth is at 9.2J08, you can talk if you are interested.

These manufacturers claim that their varieties have passed the conformity assessment, mainly because of the following two reasons:

> 1, has been listed abroad, and domestic products are regarded as passing the conformity assessment.

But I can say clearly that having been listed abroad does not mean that China will certainly pass the conformity assessment.Take a look at the foreign listing area, whether it is Europe, the United States and Japan; second, see whether the same production line at home and abroad; third, see whether the domestic and foreign composition of the same process, may be completely different raw materials.

Moreover, CDE will give priority to review all those that have been declared in China and mark the collinearity at home and abroad.If it hasn't been disclosed by the CDE, forget it.

CDE has published a total of 63 domestic and foreign collinear varieties in recent years, but only 5 have been approved.Is your family really this 1/12?

2, do BE, immediately reported.

According to medical Rubik's Cube PharmaGO data monitoring, since the verification of clinical trial data in 2015, the number of BE trials applied in China has been 1996.Of these, 1042 have been completed BE, 46 have been actively suspended, and 908 are being and just completed patient recruitment.It seems that the success rate of BE is quite high, but it must be noted that completion does not mean passing, and failure is also a state of completion.I wonder, how many failures are there?

We took amlodipine as an example and counted by variety and manufacturer, 32 BE trials have been completed, but only 19 have been declared as CDE.Why aren't the other 13 varieties reported?Why?We estimate that the results of about 40% of the BE trials may not be optimistic.

So we see the step size of today's announcement, entrusted CRO to develop voriconazole for injection, willing to pay 15 million price, only to be able to package.

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