Amgen and Sandoz Launch Biosimilars in Europe

Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets.  This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall.  According to Amgen, two Phase 3 studies confirmed that AMGEVITA showed biosimilarity to adalimumab, showing no clinically meaningful differences when used in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients.  AMGEVITA can now be marketed in twenty-eight countries that are members of the European Union, as well as Norway, Iceland, and Liechtenstein.

Sandoz’s adalimumab biosimilar, HYRIMOZ, also launched in Europe yesterday.  It is the fifth Sandoz biosimilar available in Europe.  HYRIMOZ is limited to the UK at this time, but will reportedly launch in additional European markets in the future.