Amgen has gained a European marketing authorization for its biosimilar version of Abbvie’s anti-inflammatory drug adalimumab (Humira), making it the first European license for a biosimilar to adalimumab. Amgen’s product will be called biosimilar adalimumab (Amgevita).
Biosimilar adalimumab is approved for the following inflammatory conditions in adults:
It is also approved for the following pediatric conditions:
The approval comes from results of 2 phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients, each of which met their primary endpoint with no clinically meaningful differences to adalimumab, including safety and immunogenicity data.
Approval from the European Commission (EC) means Amgen can now market the drug across 28 countries across Europe. Other European Economic Area member nations, including Norway, Iceland and Liechtenstein, will take corresponding decisions based on the EC decision.
Called adalimumab-atto (Amjevita) in the United States, Amgen gained FDA approval in September 2016. However, pending legal issues have prevented market launch.
Global sales of Humira crossed $16 billion in 2016.