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辉瑞与AbbVie达成和解,推迟Humira类似药美国上市时间

医药魔方 医药魔方 来源:医药魔方
2018-12-02
辉瑞 阿达木单抗
原文

11月30日,辉瑞宣布与AbbVie就阿达木单抗生物类似药全球范围的专利诉讼达成和解。


根据协议,在欧洲市场,辉瑞的阿达木单抗生物类似药获得EMA批准后就可上市销售。但是在美国市场,辉瑞需要2023年11月20日以后方可上市销售阿达木单抗生物类似药。双方协议的其他财务细节未见披露。


这是目前为止第7家与AbbVie就Humira专利诉讼达成和解的公司。之前6家分别是Amgen、费森尤斯卡比、三星Bioepis、Mylan、Sandoz、Momenta。其中Amgen、Sandoz的阿达木单抗类似物已经先后于2016年和2018年被FDA批准。


由于阿达木单抗在欧洲的专利保护已经到期,开发企业不再受限。但是对于美国市场,从目前7家公司签订的协议条款来看,越早与AbbVie达成和解,获得许可在美国上市阿达木单抗类似物的时间也越早。辉瑞的阿达木单抗类似药目前处于III期临床阶段。


7家与AbbVie达成和解的公司


勃林格殷格翰的阿达木单抗类似物已经在2017年获得FDA批准上市,但其与AbbVie的专利诉讼仍在进行之中。勃林格仍希望通过专利挑战,可以使自己的Cyltezo于2023年前在美国上市。


Humira是史上最畅销的药物,2017年美国市场销售收入达到123.6亿美元,其他国家和地区的市场份额累计60亿美元。目前欧洲市场对生物类似药接受度高,价格竞争也激烈。10月底一度传出Humira定价将直降80%,AbbVie随后则对这一消息进行了辟谣。但无论如何,Humira的市场竞争已经到来。


AbbVie管理层认为生物类似药对Humira的2019年销售收入影响不大。预测2019年Humira的国际收入会下降17亿美元,但美国市场的仍有10%~12%的增幅,因此2019年的全球总收入相比2018年变化不大。

机器翻译

On November 30, Pfizer announced a settlement with AbbVie on a worldwide patent lawsuit for adalimumab biosimilar drugs.

According to the agreement, in the European market, Pfizer's adalimumab biosimilar drug can be marketed after obtaining EMA approval.However, in the US market, Pfizer needs to market adalimumab biosimilar drugs after November 20, 2023.Other financial details of the agreement were not disclosed.

This is the seventh company so far to settle a Humira patent lawsuit with AbbVie.The first six are Amgen, Fresenius Kabi, Samsung Bioepis, Mylan, Sandoz, Momenta.Among them, Amgen and Sandoz's adalimumab analogues have been approved by the FDA in 2016 and 2018.

Since the patent protection of adalimumab in Europe has expired, the development enterprise is no longer limited.However, for the U.S. market, judging from the terms of the agreement signed by the current seven companies, the sooner the settlement with AbbVie is reached, the earlier the time to obtain a license to market adalimumab analogues in the United States.Pfizer's adalimumab-like drug is currently in Phase III clinical stage.

7 companies that have reached a settlement with AbbVie

Boehringer Ingelheim's adalimumab analogue has been approved for listing by the FDA in 2017, but its patent litigation with AbbVie is still in progress.Boehringer still hopes to pass the patent challenge and make his Cyltezo available in the United States by 2023.

Humira is the best-selling drug in history, with US market sales reaching 123.600 million US dollars, the market share of other countries and regions accumulated 6 billion US dollars.At present, the European market has high acceptance of biosimilar drugs and fierce price competition.At the end of October, it was reported that Humira's pricing would drop by 80%, and AbbVie later rumored the news.But in any case, Humira's market competition has arrived.

AbbVie management believes that biosimilar drugs have little effect on Humira's 2019 sales revenue.Humira's international revenue is forecast to fall by $1.7 billion in 2019, but there is still a 10% to 12% increase in the U.S. market, so total global revenue in 2019 will not change much compared to 2018.

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