Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea
Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck
Merck (MSD) has announced that Samsung Bioepis has received approval of Renflexix (infliximab), a biosimilar of the immunology medicine Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea. Merck will commercialize Samsung Bioepis’ Renflexis in Korea as part of Merck’s commercialization partnership with Samsung Bioepis to offer high-quality biosimilar alternatives to existing biologic medicines.
Samsung Bioepis’ Renflexis is indicated in Korea 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 plans to launch Renfexis in South Korea in the first half of 2016.
“Merck is committed to delivering on the promise of biosimilars and we look forward to bringing Renflexis forward to help meet the needs of physicians, patients and healthcare systems,” said Dora Bibila, general manager, Merck Biosimilars.
Merck’s commercial launch of Renflexis in Korea will include comprehensive education and support services for healthcare professionals, patients and their caregivers, including biosimilars education, disease education, and reimbursement and access support.
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