Korea Approves Biosimilar of Remicade

Approved Biosimilar Products

On December 7 Samsung Bioepis and Merck announced that Samsung Bioepis had received approval for its RENFLEXIS product by the Ministry of Food and Drug Safety in Korea. RENFLEXIS, a biosimilar version of Janssen Biotech’s Remicade (infliximab), was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis in adult patients (age 18 years and older). Merck has partnered with Samsung Bioepis on this drug and will be commercializing the drug in Korea, beginning in the first half of 2016.

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