Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October.  On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched 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 October 16, 2018.  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.

On October 17, 2018, Biogen and Samsung Bioepis additionally announced their European launch of IMRALDI.  IMRALDI is the third anti TNF biosimilar developed by Samsung and commercialized by Biogen across Europe.

Just a few days later, on October 19, 2018, Mylan launched biosimilar HULIO, across major markets in Europe.  Mylan mentioned is partnership with Fujifilm Kyowa Kirin Biologics, referencing the “strong collaboration of [Mylan’s and Fujifilm’s] science and technology teams to bring Hulio to market for patient.”  The availability of HULIO marks the fourth product in the area of complex generics and biosimilars that Mylan is bringing to market in Europe.

Notably, in view of the launches of Humira biosimilars in Europe, it was recently reported that AbbVie reduced its Humira European price tag by 80 percent.

Download PDF