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"专利战争"-诺华和安进继续为Neupogen生物仿制药“厮打”

来源:生物谷 2015-03-03 09:19

2015年3月3日讯/生物谷BIOON/ --因为诺华仿制了安进的重磅炸弹药物Neupogen,两家公司最近开始了一场激烈的“争夺战”。

最近的事件中,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。该生物仿制药如果得到FDA的批准,将成为美国上市的首个生物仿制药,意义重大。

这场争斗从诺华向FDA提交Neupogen的生物仿制药开始。该申请在去年7月份获得受理,成为FDA成立以来审评的第一个生物仿制药。更早期的时候,由于FDA没有制定生物仿制药审评和批准的法规框架,美国因此在Biosimilar领域落队,在全世界其他很多国家,人们都可以相对容易地获得昂贵生物制品的廉价版本-Biosimilar。然而,在2010的专利保护和可支付医疗法案的指导下,FDA现在有权利批准生物仿制药。

生物仿制药由于来源于有生命的细胞,必须对工艺进行非常详细的评估以验证其临床安全性和有效性,所以生物仿制药不可能是原研药品完全一致。今年1月5日,经过仔细的评估,肿瘤药物咨询委员会推荐批准诺华的Neupogen生物仿制药,由于结果表明了该仿制药与原研药在安全和有效性方面的一致性。评委专家提到该仿制药在符合“原研药和仿制药在安全,纯度和效力方面无临床意义的差异”这一评价标准。

诺华原计划在FDA批准后最早于3月8日上市,然而安进在2月6日对其提交诉讼,理由是"侵犯专利"。法院计划在3月2日举行一次双方的口头谈话。很明显,仿制药的上市对安进造成了严重的威胁,而且有分析称,该生物仿制药的上市最早可能在2016年便使原研药失去“重磅炸弹”的地位。

然而,现在该生物仿制药的上市面临推迟,由于听证会被推迟到3月13进行。

关于“安进要求阻止Neupogen生物仿制药上市”的判定结果预计在4月10日公布。诺华已经同意在结果宣布之前不上市该产品。

Neupogen的生物仿制药已经在其他市场上市多年。诺华自己也已经从2009年开始在40多个国家上市了Neupogen的生物仿制药-商品名Zarzio。Zarzio是全世界排名领先的生物仿制药,在欧洲占据了大约30%的份额。

Neupogen是用来治疗中性粒细胞减少的癌症患者,其专利于2013年过期。尽管如此,该药物在2014年还是取得了12亿美金的销售额。分析师预测,该药物的销售额预计会按照8.6%年复一年地减少。预计到2016年,销售额为9.85亿美金,这对安进公司的销售额很明显是一个严重的威胁。

关于Neupogen生物仿制药的竞争也愈演愈烈,前不久,Apotex刚刚宣布FDA受理了其Filgrastim生物仿制药的申请(相关阅读:Apotex宣布FDA受理Filgrastim生物仿制药的申请),这已经是Apotex公司在美国通过由生物仿制药价格竞争和创新法案(BPCIA)创建的351(k)简化审批途径向FDA递交的第二个生物仿制药申请。Apotex公司之前通过351(k)简化申请途径提交的另一个产品是PEG化长效Filgrastim非格司亭制剂,目前也正处于FDA审评阶段。 Apotex公司也是至今唯一一家有两个FDA在审生物仿制药(PEG-Filgrastim and Filgrastim)的幸运者。

全球医疗系统由于资金短缺将进削减开支,许多制药公司包括韩国 Celltrion 公司等抢在大市场份额的生物制剂专利到期之前,竞相研发生物仿制药。而且,进来Celltrion在生物仿制药领域利好消息不断,尤其是在其领先的Remicade仿制药领域,最近又顺利打开了欧洲更大的市场 Celltrion在12个欧洲国家新上市单抗生物类似药Remsima?(相关阅读:Celltrion在12个欧洲国家新上市单抗生物类似药Remsima)。

据路透社生物世界报道,生物仿制药的价格通常会低于原研药的 20% 到 30%,预计在近十年里非专利生物制剂 1000 亿美金市场占有四分之一的份额。

目前Biosimilar领域领先的Game player有Teva,Celltrion,Hospira和Samsung Biologics等。

关于Neupogen(filgrastim):

Neupogen(通用名:filgrastim,非格司亭)是安进应用重组DNA技术生产的甲硫氨酸人粒细胞集落刺激因子(Granulocyte colony-stimulating factor,G-CSF),可促进造血辅助细胞增殖分化,明显增加外周血中性粒细胞数,并有增强粒细胞的功能,如对成熟的中性粒细胞可增强其吞噬活性和抗体依赖性细胞介导的细胞毒作用。

Neupogen适用于:(1)促进骨髓移植后中性粒细胞的恢复;(2)治疗肿瘤化疗后中性粒细胞减少症;(3)治疗伴随骨髓异常增生综合征之中性粒细胞减少症;(4)治疗伴随再生不良性贫血之中性粒细胞减少;(5)治疗先天性、特发性中性粒细胞减少症。(生物谷Bioon.com)

Novartis AG, Amgen, Inc. Tussle Over Neupogen Biosimilar Continues

Amgen has filed a petition asking the court to block the launch of Neupogen’s biosimilar, developed by Novartis

Novartis AG ADR (NYSE:NVS) and Amgen Inc (NYSE:AMGN) have recently been involved in a tussle over the biosimilar imitation drug developed by Novartis for Amgen’s blockbuster biologic drug, Neupogen.

In recent events, Amgen has sued Sandoz, a Novartis subsidiary, for patent infringement and unfair competition, as reported by Bloomberg Intelligence. Amgen has filed a petition, asking the court to stop the launch of Neupogen’s biosimilar. The biosimilar, if approved by the US Food and Drug Administration (FDA), would be the first ever biosimilar drug to be marketed in the US.

The tussle began when Novartis filed its application for Neupogen’s biosimilar to the FDA. The application for the imitation drug was accepted in July, making it the first-ever biosimilar to be reviewed by the FDA. Earlier, the US did not make a legal framework for the approval of the biosimilar drugs, and thus the country lagged behind many other regions, where people can easily access the cheaper version of the expensive biologic drugs. However, under the Patent Protection and Affordable Care Act 2010, the FDA is now authorized to approve biosimilars.

Since biosimilars are not the exact same copies of the biologic drugs, which are developed from living cells, a very thorough evaluation process has been devised to test their safety and efficacy. After evaluation, Oncologic Drugs Advisory Committee for FDA recommended approval for Novartis’s biosimilar for Neupogen on January 5, as it demonstrated similar safety and efficacy profiles to the original drug. The reviewers mentioned that the biosimilar “meets the requirement for a demonstration of ‘no clinically meaningful differences’ between the proposed product and the reference product in terms of safety, purity, and potency.”

Novartis was said to launch the biosimilar as early as March 8, contingent upon the FDA approval, but Amgen filed a suit against the company on February 6, based on patent infringement; the court scheduled an oral dialogue between the companies on March 2. The launch of the imitation drug poses a serious threat to Amgen, as the launch of biosimilar can take away the blockbuster status of the original drug as early as 2016.

However, the launch of the biosimilar is now facing delays, as the hearing on Amgen’s injunction bid to block Novartis’s biosimilar has been postponed to March 13.

The decision on Amgen’s request to block the launch of Neupogens’s biosimilar is expected to be announced by April 10. Novartis has agreed to not launch its product before the decision is announced. The company has also agreed that it will give Amgen a five-day notice to the launch of the biosimilar, if the court decides in favor of Novartis before April 10.

For Neupogen, Biosimilars have been in other markets for years now. Novartis itself markets the biosimilar imitation version of Nuepogen in more than 40 countries with the brand name, Zarzio since 2009. Zarzio is one the leading biosimilars worldwide with a market share of approximately 30% in Europe.

Neupogen, drug approved to treat neutropenia in cancer patients, lost its patents in 2013. Despite patent expiration, the drug managed to rake in $1.2 billion sales in 2014. According to analysts’ forecasts, the revenue generated by the drug is estimated to see an 8.6% Year-over-Year decline, totaling up to $1.05 billion only for the current year. For 2016, analysts have forecasted $985 million sales for Neupogen, indicating the severe threat, which the biosimilars are posing to the company’s revenues.


 


 
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