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2014年医药产业“兵器谱”出炉,十大畅销药横扫世界

来源:生物谷 2015-02-17 10:04

 

2015年2月17日讯 /生物谷BIOON/ --古龙曾经说过,有人的地方就有江湖。如果把医药产业比作纷乱的江湖,各大医药公司比作一位位绝世高手,那么这些生物医药公司旗下的畅销药物可谓是这些"高手"们的神兵利器。因此,每年的畅销药物排行榜也就成为了"江湖中人"关注的重中之重。最近,分析人士统计出了2014年生物医药产业销售额最高的十大药物。这十种药物的销售总额达到了惊人的830亿美元之多,更引人瞩目的是其中的生物制药占据了七种之多。其中的前三甲分别是艾伯维公司的Humira、吉利德公司的Sovaldi以及强生和默沙东公司共有的Remicade,而Humira以及Sovaldi的年销售额均突破了100亿美元,分别达到了125亿美元和108亿美元之多。而这远远不是结束,预计到2020年这两种药物的销售额将分别上升至147亿美元和166亿美元以上。而按照药物的适应症进行归类,治疗癌症的药物占据了排行榜中的六席,此外治疗糖尿病的药物有两种上榜,分别是赛诺菲的Lantus和默沙东的Januvia。可以说,这些畅销药物已经成为了这些生物医药巨头占据生物医药市场领导地位的杀手锏。

不过,这些生物医药公司也都有着各自的远虑近忧。资料显示,2014年的十大畅销药中又数种都即将失去专利保护。这也意味着这些药物将面临着来自各个仿制药的强烈竞争。以此次的榜首--艾伯维公司的Humira--为例,尽管这一药物已经为艾伯维带来了数以百亿计的收益,但是随着仿制药的围攻,Humira的销售峰值预计将从2017年的160亿美元跌落至2022年的60亿美元。另一方面,随着美国政府医疗改革的进程,美国医保体系中药物价格过高的问题已经遭到了美国政府和民众的猛烈抨击。以吉利德公司的Sovaldi为例,这种治疗丙肝药物于2013年十二月上市后,因为其极其明显的疗效迅速席卷美国市场。然而Sovaldi每疗程的价格高达84000美元(即每片药物1000美元),不仅让人想起中国的一句俗话"十个劫道的不如一个买药的"。而FDA和美国的政府部门也紧急出台了多种政策旨在控制今后的新药价格。这两方面的问题都将对未来生物医药市场产生极大的影响。

正所谓江山代有才人出。在生物医药市场,没有人会是永远的赢家。今天的畅销药或许在明天就会被新的药物所取代。只有不断保持警惕和锐意进取才能保证在这个竞争激烈的领域立足。(生物谷Bioon.com)

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详细英文报道:

It is no wonder that biosimilar bulls are emerging. The 10 biggest selling pharmaceutical products in 2014 generated combined sales of $83 billion, of which $60 billion was generated by seven biologic drugs, most of which will lose exclusivity for key patents by the end of the decade.

The 'value' of this commercial opportunity has long been touted by biosimilar developers and, of course, only represents one part of the equation. Both the development and regulatory environments continue to provide a multitude of challenges, while convincing physicians and patients to use biosimilars at the expense of heavily entrenched brands is likely to prove the most difficult challenge of all - the flip side to the potential 'demise' of these products is their impressive longevity in the market.

However, an intensification of the debate around pricing in the US drug market and concerted regulatory momentum from the FDA in the past few months will frame this list of best-selling medicines in a slightly different light to previous years, when the prospect of significant biosimilar erosion appeared just that little bit less tenable.

In a note to investors published last week, Citi analysts led by Andrew Baum have taken the most bullish stance yet on the biosimilars opportunity; one headline grabbing conclusion from Citi's research is that sales of AbbVie's anti-TNF therapy Humira will decline from a peak of $16 billion in 2017 to $6 billion by 2022.

The rest of the analyst community are yet to reach the same conclusion; consensus forecasts sourced from Bloomberg indicate healthy sales of $14.8 billion for Humira in 2020, while it should be noted that Citi's outlook is not all doom and gloom; cost savings sourced from the use of biosimilars will be used to fund uptake of novel therapies, with Baum among the most bullish about the immuno-oncology market among his peers.

The Citi outlook is partly based on the notion of US pharmacy benefit managers - empowered by their success in the hepatitis C market - targeting the anti-TNF class for rapid adoption of biosimilars. It is Celltrion's biosimilar version of the anti-TNF Remicade - which is to be assessed by an FDA AdCom panel next month - that may provide the first opportunity for Citi's scenario to play out.

Consensus forecasts suggesting that Remicade sales will decline to around $7.6 billion by 2020 illustrate the Johnson & Johnson and Merck & Co.-marketed product as being the most exposed to direct biosimilar competition. Not only could Celltrion's product feasibly be approved by the FDA later this year, but is already cleared in Europe and on the verge of launching in some of the region's largest markets (Physician Views Poll Results: Let the games begin - Remicade biosimilar free to debut in EU5 markets).

Sanofi's basal insulin product Lantus is also set to face biosimilar competition (from Eli Lilly) in Europe this year, although a forecast decline in sales over the next five years primarily reflects a more challenging US price environment, loss of share to competitors and the switching of patients to Sanofi's Toujeo franchise, which is expected to gain FDA approval later this year.

Mirroring Sanofi's Toujeo strategy it is not surprising that 'successor' products to three other drugs on the list have launched in the past few years. Roche has sought to reduce its top line to exposure from biosimilar competition by launching Gazyva as a mooted successor to Rituxan with Perjeta and Kadcyla positioned as follow-ons to Herceptin (with this strategy a mixed success following publication of the MARIANNE data in December).

GlaxoSmithKline has sought to maintain leadership of the asthma and COPD markets via the launches of Breo Ellipta and Anoro Ellipta. While Advair has lost share over the past year in the US due to pricing dynamics, however, both Breo and Anoro have underwhelmed since launch. As a result, emphasis is building on a triple combination therapy in Phase III development but Advair looks well set to remain the biggest selling respiratory drug of all time. A key point of debate is whether Advair will face generic competition in the US next year; consensus suggests not, but this is a potential 'black swan' event in waiting for the UK player.

The final word must go to Gilead Sciences' Sovaldi hepatitis C franchise, which generated sales of $10.3 billion in 2014, a staggering performance following first launch in December 2013. Factoring in sales of Harvoni (a combination of Sovaldi with ledipasvir), franchise revenues swell to $12.4 million (Harvoni only launched in December 2014).

Sovaldi/Harvoni has not only emerged as the fastest drug launch of all time, but a controversial product that has stirred much of the current debate around US drug pricing. Whether the franchise can overtake Humira and Pfizer's Lipitor as the biggest selling remains to be seen, but consensus indicates 2020 sales of around $16 billion.

 

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