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黑云压城,Neupogen之争虽画句号 仿制药市场前景仍存未知数

来源:生物谷 2015-03-22 10:26

2015年3月22日讯 /生物谷BIOON/ --近年来仿制药市场已经成为了生物医药产业增长最为迅速的市场之一。随着各大生物制药巨头旗下的众多明星药物即将失去专利保护,许多厂家纷纷磨刀霍霍,希望在这未来的新兴市场中分上一杯羹。不过,原版药物拥有者自然是竭尽全力希望防止或者延缓仿制药对其的挑战。

诺华公司去年7月份向FDA提交了关于安进畅销药物Neupogen的仿制药申请,并与最近获得了FDA的批准并成为了美国市场首个获批的仿制药物。这也直接导致安进公司彻底不淡定,并向美国法院起诉Amgen起诉了诺华的子公司-Sandoz,原因是"专利侵权和不公平竞争"。Amgen提交了一份请愿书,要求法院停止上市Neupogen的生物仿制药。(相关阅读:"专利战争"-诺华和安进继续为Neupogen生物仿制药"厮打")不过,最近美国法院最终做出了决定,驳回了安进公司的质控,支持诺华公司仿制药继续上市,为这一争斗暂时画上了一个句号。

然而,围绕着仿制药市场,人们仍有诸多疑虑。其中最大问题就是仿制药在美国的前景是否向某些生物医药公司预期的那样美好?一些分析人士认为这一市场规模充其量也只能达到350亿美元左右,而乐观人士则直接给出了2000亿美元的结论。质疑者举出了目前仿制药市场较为成熟的欧洲市场为例,仿制药的出现并未从根本上颠覆原版药物的生存空间。然而,反对者则表示欧洲市场生态环境与美国有明显不同,一旦质优价廉的仿制药上市,作为支付主体的美国保险公司体系极有可能转而支持这些药物,并最终促进仿制药市场的规模。

而目前一些生物医药巨头似乎也是赞同这一看法。不久之前辉瑞公司就豪掷150亿美元收购Hospira作为进入仿制药市场的桥头堡。而如今诺华与安进公司仿制药之争的落幕无疑会增强仿制药支持者们的信心。(生物谷Bioon.com)

详细英文报道:

But legal fight continues to cloud the dawn of the biosimilar era

Novartis ($NVS) CEO Joe Jimenez was a bit dismissive about the immediate impact of biosimilars when his company became the first to get one approved in the U.S. But Amgen ($AMGN) didn't see the biosimilar of its blockbuster Neupogen in quite the same light and tried to stop its release. Unfortunately for the company, a federal judge denied Amgen's request for a temporary injunction.

Neupogen fights infections in cancer patients and the FDAapproved Novartis' copy earlier this month but the release was halted by Amgen's court action. Thursday's decision allowing the release of Novartis' drug Zarxio does not a put an end to the fight. Amgen said it would appeal Thursday's ruling. Novartis, theWall Street Journal reports, had held off on the release of Zarxio until the court ruled but didn't say if it would do the same while the decision is appealed. Amgen has said that it might also take Novartis to court with its contention that Zarxio violates patents of Neupogen, a drug that raked in $1.2 billion last year.

Of course other biosimilar developers are anxiously watching to see what kinds of legal mud wrestling they might get into when their own drugs are approved. More importantly, they want the drug to get to market to see how doctors and patients respond to the copies of biologic drugs.

There have been widely varying projections of just how grand the biosimilar market will be financially. Some say only $35 billion this decade, while others forecast closer toward $200 billion. Their uptake in Europe, where they have been available for years, has been tepid. But then again, Europe's national payer market is a different animal than the U.S. where pharmacy benefit managers (PBMs) have a lot to say about which drugs are paid for under employer health plans. Troyen Brennan, chief medical officer for CVS Health ($CVS), told Reuters this month that the PBM sees biosimilars coming in at discounts of 40% to 50%, which is more aggressive than the 20% estimates that have been floating around for years.

Pfizer ($PFE) is confident enough about the market that it recently agreed to pay $15 billion for Hospira ($HSP), in part, because of its foothold in the biosimilar market. Hospira and its biosimilar partner Celltrion have a copy of Johnson & Johnson's ($JNJ) blockbuster autoimmune drug Remicade pending before the FDA but last month the agency said it was delaying a meeting that had been set for this week for consideration of their drug while the two fed the agency some more info.

It is these kinds of issues that left Novartis' Jimenez sanguine about his company being the first to file for a biosimilar application. While he expects Novartis' generic unit Sandoz to be a big player in the biosimilar business, and for the biosimilar business to be big, he said that it will take at least 5 years before the industry knows how regulators, payers, patients and healthcare providers will take to them. "By the year 2020, which is just 5 years from now, you're going to see a big impact," he said at the time.

 

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