#Biosimilars
今日AbbVie宣布了新的专利许可协议
针对Mylan的Humira生物类似物
在欧洲以外市场的专利许可
该产品为Mylan自富士-协和麒麟生物(FKB)引进
与Biocon共同开发
这也是与AbbVie达成许可协议的第三款产品
去年销售额184.3亿美元
扛起了AbbVie六成左右的年收入
除去没有达成协议的BI
三款产品上市时间
将分别间隔5个月和1个月
Amgen具有市场先发优势
以下为三款产品美国最早上市时间
2023/1/31 星期二
1
Amgen
美国上市时间
2023/6/30 星期五
2
Samsung Bioepis/MSD
美国上市时间
2023/7/31 星期一
3
Mylan
美国上市时间
Chugai获得Roche收购的ROS1/TRK抑制剂
Entrectinib
日本市场独家开发权
目前该产品已经获得
FDA授予的突破性疗法资格
EMA授予的优先药物计划
日本厚生劳动省授予的Sakigake资格(先驱资格)
NORTH CHICAGO, Ill., July 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV) announced today patent license agreements with Mylan over its proposed biosimilar adalimumab product. Under the terms of the agreements, AbbVie will grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to HUMIRA in the United States and in various other countries around the world in which AbbVie has intellectual property, excluding Europe.
Mylan’s U.S. license will begin on July 31, 2023, and will not be accelerated by Amgen’s or Samsung Bioepis’ entry. Mylan will pay royalties to AbbVie for licensing its HUMIRA patents once its biosimilar product is launched. Mylan acknowledges the validity of the licensed patents. AbbVie will make no payments to Mylan.
“AbbVie’s HUMIRA patents reflect the groundbreaking work of AbbVie scientists in the field of fully-human biologics and our investment in patient-focused innovation,” said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary, AbbVie. “We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its HUMIRA biosimilar maintains that balance.”
On September 28, 2017, AbbVie announced a global resolution with Amgen to enter the U.S. on January 31, 2023, and on April 5, 2018, AbbVie announced a similar resolution with Samsung Bioepis to enter the U.S. on June 30, 2023.
始发于微信公众号： Pharmews