First Humira biosimilar approved in Europe
Published 27 Mar 2017
The European Commission has approved Amgevita (biosimilar adalimumab) in all the available indications of its originator product, marking the first European licence for a biosimlar version of Humira. Amgen said it had authorisation for “all available indications” for its biosimilar Humira, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis and moderate-to-severe Crohn's disease. Sean Harper, executive vice president of research and development at Amgen, said: "The approval of our first biosimilar by the European Commission is a major milestone not just for Amgen as a company, but for the millions of patients with chronic inflammatory diseases who need alternative treatment options. In addition, Amgevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option. This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines."
The EC approved Amgevita after its scientific advisors concluded the biosimilar was highly similar to Humira, with studies showing it had comparable quality, safety and efficacy to its originator.
Amgen said the data it submitted to the regulators included results from two phase 3 studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. Both met their primary endpoints, showing no clinically meaningful differences to Humira and comparable safety and immunogenicity for Amgevita.
Facebook
Twitter7 comments
i take humira for r/h. am in remission at the moment not sure if i would like to change.
I'm just hoping this drug will be available soon in ireland. I am willing to try it out and hope it will be just as good as humira.
I was on humira, and developed a rash as a result . Never got to give it a good run as a result . I am on Simponi now and it is beginning to lose its effect . Where to now ?
Hi! just to say that it myself have been on Humira for a number of years then the effectiveness started to wear of and was sore on the immune system, was charged to the Simponi Golimumab at 100mg every month, unfortunately this has it effects on the immune system, I have had a run of chest infection's one that took about six weeks of strong antibiotic's to shift it, I am just been put back on both Methotrexate and Golimumab injections in the hope that it will ease my pain and discomfort.
I've been on Humira for a few years now and I get on well with it. I'm not sure if I'd want to change now. Watch this space I guess...
