仿制药

仿制药申报中有关包装的内容。

Package related parts in anda .

陈冯富珍表示，世卫还邀请仿制药生产商开始生产抗病毒药。

The WHO has also invited generic drug makers to start producing antiviral drugs , she added .

FDA仿制药申请生物等效性数据资料提交指导原则介绍

Interpretion of FDA guidance on submission of summary bioequivalence data for abbreviated new drug application

FDA发布经皮仿制药对皮肤刺激性和过敏性临床试验的设计及评分系统

Designs and scoring systems of FDA issue to skin irritation and sensitization clinical trial of generic transdermal drugs

boots等医药零售商往往从批发商或直接从仿制药生产企业手中购买仿制处方药。

Chemists , such as boots , tend to buy their generic prescription drugs from wholesalers or directly from generics manufacturers .

美国食品和药品监督管理局（FoodandDrugAdministration）现已批准了至少三种鱼油产品——Vascepa、Lovaza（ω-3脂肪酸乙酯胶囊）和一种仿制药——作为治疗甘油三酯过高（心脏病的一个风险因素）的处方药。

And the Food and Drug Administration has approved at least three prescription types of fish oil - Vascepa , Lovaza and a generic form - for the treatment of very high triglycerides , a risk factor for heart disease .

但无论是仿制药生产厂商还是FDA都不会与被仿药物有所差异的仿制药品进行上市后研究。

But neither generic-drug manufacturers nor the FDA does post-marketing studies that might indicate patients are responding differently to a generic than to its brand-name counterpart .

对于PD-L1呈阴性的肿瘤患者而言，纳武单抗与化疗仿制药多西他赛（docetaxel）的效果无异。

For those with PD-L1-negative tumors , there was no real difference between Opdivo and the generic chemotherapy drug docetaxel .

“该批准是FDA在法律许可范围内，尽快增加安全有效的仿制药替代品使用的另一个例子，”FDA的仿制药办公室主任GaryJ。

" This approval is another example of our agency 's efforts to increase access to safe and effective generic alternatives as soon as the law permits ," said Gary J.

通过谈判，葛兰素史克获得了在非洲以外市场销售Aspen旗下1200种仿制药并分享利润的优先权。

The pharmaceuticals group has negotiated first right of refusal to sell and share profits on any of the 1,200 generic products owned by Aspen for markets outside Africa .

UNITAID的艾滋病专利池意味着可以立刻生产仿制药，而且可以开始进行新药联用以及对儿童友好的配方的研究。

The UNITAID HIV patent pool would mean generics could be made immediately , and research could begin into new drug combinations and child-friendly formulations .

尽管没有标准或者法规来特别描述片剂刻痕的要求，FDA认为有必要保持仿制药和RLD之间刻痕的一致性。

Although there are no standards or regulatory requirements that specifically address scoring of tablets , the Agency recognizes the need for consistent scoring between a generic product and its RLD .

一些中国制药商正在尝试完成从仿制药到创新药的飞跃，先声药业（SimcerePharmaceuticals）就是其中一家，它最近在南京成立了研发中心。

One of those trying to make the leap from generic to innovative medicines is Simcere Pharmaceuticals , which recently opened an R & D hub in Nanjing .

但研究者说直到PEPFAR使用仿制药后，抗击艾滋病毒和艾滋病采取重大进展。

But researchers say it was not until PEPFAR started using generic drugs that major progress was made in fighting HIV / AIDS .

法国医药巨头赛诺菲安万特公司在2010年收购巴西公司Medley之后一跃成为拉美地区最大的仿制药生产企业。

Sanofi-Aventis , a French giant , has become the biggest producer of generic drugs in Latin America after its purchase in 2010 of Medley , a Brazilian firm .

但是，Bhatt说，这个仿制药市场充斥着假药，而且缺乏行业管理。

But , says Bhatt , the market is flooded with counterfeits , with no regulation of the industry in sight .

强生公司、Gilead以及印度的仿制药制造商Cipla已经公开表示支持，据报道诺华和默克也正在与UNITAID协商。

Johnson and Johnson , Gilead , and Indian generics-maker Cipla have been openly supportive , and Novartis and Merck are reportedly in talks with UNITAID .

Klonopin（仿制药：氯硝西泮）（0.5mg的）：这是一个长效苯二氮类，多年来我最有效的药物。

Klonopin ( generic : clonazepam )( 0.5mg ): This is a long acting benzodiazepine , and my most effective drug over the years .

日本制药集团海外扩张的努力——包括第一三共株式会社（DaiichiSankyo）以47亿美元灾难性地收购印度仿制药生产商Ranbaxy——也没有带给人鼓舞。

Efforts by pharma groups to expand abroad , including Daiichi Sankyo 's disastrous $ 4.7bn acquisition of Ranbaxy , an Indian generics maker , have not inspired confidence .

这将中国置于类似印度的地位上，印度的鲁宾（Lupin）和兰伯西（Ranbaxy）已成为大型仿制药生产商，但似乎没有自行研发高价值药物的迹象。

This puts China in a similar position to India , where companies such as Lupin and Ranbaxy have become big generic manufacturers but show little sign of developing their own high-value medicines .

我注意到，在Barr产品的6个月的独占期结束后，没有人愿意在放飞的翅膀中等待，因此，这正是位于长尾上的那些好的仿制药产品之一。

There 's nobody I 'm aware of that is waiting in the wings to launch after Barr 's six months of exclusivity , so this could be one of those nice generic products with long tail on it .

问题在于，严格的打假行动和模糊的立法倾向于也把基本的仿制药作为目标。一些科学家非常担心一个新的反造假条约&欧洲理事会的MEDICRIME反假冒公约。

Some scientists are very concerned about a new treaty to combat counterfeit drugs , the Council of Europe 's Medicrime Convention .

102个国家的仿制药厂商将可生产艾伯维的洛匹那韦（lopinavir）和利托那韦（ritonavir）药物。几乎所有感染了艾滋病病毒的儿童都生活在这102个国家。

AbbVie 's lopinavir and ritonavir drugs will be available to generic producers in the 102 countries where almost all children with HIV live .

在MGI分析的12个效率驱动型行业中的9个行业，比如太阳能板、仿制药和钢铁，中国占全球收入的份额都高于2013年中国占全球GDP约12%的份额（如最后一张图表所示，见下）。

In nine of the 12 efficiency-driven industries MGI analysed , such as solar panels , generic pharmaceuticals and steel , China 's share of global revenues is greater that its share of global GDP , at some 12 per cent as of 2013 ( see the last chart ) .

比如，Halozyme公司的重组透明质酸酶就是这方面的实例，提供了仿制药革新的新选择。

This is where , for example , Halozyme 's recombinant hyaluronidase technology is really at the forefront of this trend in terms of providing differentiation from biosimilars for innovators .

如果你是外行，你也许这么看仿制药：他们和专利药完全一致，只是包装不同。

To a surprising degree , they say , the answer is No.

美国仿制药管理的法制历程及其对我国的启示戒酒药双硫仑

Legal Course of Generic Drug Management in USA and Its Enlightenment to China

仿制药必须含有与原配方药相同的活性成分。

A generic must contain the same active ingredients as the original formulation .

付钱给竞争对手，让他们下架仿制药？

Paying competitors to shelve generic brands of drugs ?

美国市场上含辛伐他汀的药品有单一成分的辛伐他汀仿制药及商品名药舒降之。

Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor .