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Samsung Bioepis¡¯s Stelara biosimilar Epyztek is approved

By Son, Hyung-Min | translator Kim, Jung-Ju

24.04.12 08:41:24

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The autoimmune disease drug Stelara becomes the first biosimilar to be approved in Korea

Confirmed clinical bioequivalence in Phase III trial



Samsung Bioepis announced on the 11th that it has obtained the first biosimilar approval in Korea for its autoimmune disease treatment Stelara biosimilar, Epyztek (project name SB17), from the Ministry of Food and Drug Safety.

Stelara, which was developed by global pharmaceutical giant Janssen, is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Epyztek is the fourth autoimmune disease treatment developed by Samsung Bioepis, following Etoloce (Enbrel biosimilar), Remaloce (Remicade biosimilar), and Adaloche (Humira biosimilar).

With the approval of Epyztek, Samsung Bioepis will now have three tumor necrosis factor-alph

Son, Hyung-Min(shm@dailypharm.com)
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