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Celltrion receives CHMP positive opinion for 4 biosimilars

By Chon, Seung-Hyun | translator Alice Kang

24.12.17 05:37:37

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European Medicines Agency¡¯s Committee for Medicinal Products for Human Use (CHMP) recommends approval of Celltrion¡¯s Actemra, Eylea, Prolia, and Xgeva biosimilars.



Celltrion announced on the 16th that the. European Medicines Agency¡¯s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorizations for its 4 biosimilar candidates.

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)
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