First Humira biosimilar approved in Europe
- 130 views
- 1 support
- 7 comments
All comments
Joined in 2017
24 comments posted |
Rewards
-
Good Advisor
-
Contributor
-
Explorer
Joined in 2017
Joined in 2015
14 comments posted |
Rewards
-
Good Advisor
-
Contributor
-
Committed
-
Explorer
Joined in 2017
24 comments posted |
Rewards
-
Good Advisor
-
Contributor
-
Explorer
Margarita_k
Community managerGood advisor
Margarita_k
Community manager
Last activity on 07/10/2020 at 11:39
Joined in 2016
1,195 comments posted | 154 in the News from the media group
1 of their responses was helpful to members
Rewards
Good Advisor
Contributor
Messenger
Committed
Explorer
Evaluator
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.
Pharmatimes.com