Celltrion receives CHMP positive opinion for 4 biosimilars
By Chon, Seung-Hyun | translator Alice Kang
24.12.17 05:37:37
°¡³ª´Ù¶ó
0
European Medicines Agency¡¯s Committee for Medicinal Products for Human Use (CHMP) recommends approval of Celltrion¡¯s Actemra, Eylea, Prolia, and Xgeva biosimilars.
With the recommendations, Celltrion¡¯s 4 biosimilar versions for Actemra, Eylea, Prolia, and Xgeva are expected to be approved in Europe. The biosimilars are named Avtozma, Eydenzelt, Stoboclo, and Osenvelt, respectively.
Avtozma is a biosimilar version of the original Actemra, which is used to treat autoimmune diseases such as rheumatoid arthritis and giant cell arteritis. Celltrion¡¯s biosimilar demonstrated bioequivalence and similarity to the original in a global Phase III clinical trial. The
Chon, Seung-Hyun(1000@dailypharm.com)
If you want to see the full article, please JOIN US (click)