#Biosimilars
本周二开始
欧洲市场Humira类似物陆续上市
包括Amgen/Sandoz/Biogen
以上几家制药企业
均已经与AbbVie达成和解协议
而在今日
AbbVie又宣布一项和解协议
授权Humira类似物MSB11022
来自德国制药企业
Fresenius Kabi
美国上市时间在相应延后至
2023.09.30
与上周的Sandoz和解协议一致
欧洲则是其获批之日
该产品上市申请已经于
去年12.18递交给EMA
那么现在Boehringer Ingelheim
就显得比较尴尬了
与AbbVie的专利纠纷何时才能了
NORTH CHICAGO, Ill., Oct. 18, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV) announced today global resolution of all intellectual property-related litigation with Fresenius Kabi over its proposed biosimilar adalimumab product. Under the terms of the settlement agreements, AbbVie will grant to Fresenius Kabi a non-exclusive license to AbbVie’s intellectual property relating to HUMIRA beginning on certain dates in certain countries where AbbVie has intellectual property:
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In the U.S., the Fresenius Kabi license period will begin on September 30, 2023 and will not be accelerated by the entry of companies who have already taken a license.
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In the European Union, Fresenius Kabi can launch upon approval from the European Medicines Agency.
Fresenius Kabi will pay royalties to AbbVie for licensing its HUMIRA patents and acknowledges the validity of the licensed patents. AbbVie will make no payments to Fresenius Kabi. The precise terms are confidential between the parties. All litigation pending between the parties will be dismissed.