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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:


Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.