Amgen and Novartis have outrun Samsung and Mylan in the race to get their approved biosimilar versions of AbbVie’s Humira (adalimumab) to market.
Amgen will launch Amgevita in markets across Europe beginning on Oct. 16, 2018. Amgevita is the first adalimumab biosimilar to be approved by the European Commission (EC). At the same time, Novartis’ Sandoz unit announced that it will launch its Humira biosimilar Hyrimoz initially in the UK, with other markets set to follow.
In 2017, Amgevita became the first Humira biosimilar approved in Europe, with the product authorized in all indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. Amgevita will be available in a prefilled syringe and pre-filled pen.
Regulators in Europe also have approved Samsung Bioepis’ Imraldi, and Mylan and Fujifilm Kyowa Kirin Biologics’ Hulio, both biosimilar versions of Humira set to launch in the Europe. However, Boehringer Ingelheim’s version, called Cyltezo, will not be launched in Europe due to ongoing patent litigation with AbbVie in the U.S.
Just last week, AbbVie and Sandoz reached a global resolution of all intellectual property-related litigation over Hyrimoz, in which AbbVie granted Sandoz a non-exclusive license to intellectual property relating to Humira.
