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.
Related News
-
News Swiss pharma industry warns US tariffs could harm global patient care
The Swiss pharmaceutical sector has raised alarms over new US tariffs on medicines, warning of disrupted supply chains, increased costs, and delayed innovation, all of which could jeopardise patient access to essential treatments worldwide.
-
News Women in Pharma: CPHI India – India’s Pharmaceutical Industry and Gender Inclusion Challenges
India’s pharmaceutical industry has emerged as a significant player in the global market, valued at USD 50 billion in FY 2023-2024, according to Frost & Sullivan’s analysis. This sector encompasses a diverse portfolio, including drugs, vacc... -
News Biogen acquires Apellis Pharmaceuticals to boost immunology and rare disease profile
Biogen Inc. has announced its acquisition of Apellis Pharmaceuticals, Inc., a move that is set to significantly enhance its growth portfolio in immunology and rare diseases. The agreement, valued at approximately US$5.6 billion, will see Biogen purchas... -
News Gilead Sciences acquires Ouro Medicines for over US$2 billion
Gilead Sciences confirms a deal to take over Ouro Medicines, adding to a portfolio of therapies for autoimmune diseases.
-
News Women in Pharma: Advancing Women's Health
Discover the latest innovations in technologies and therapeutics that are revolutionising women's health in our latest CPHI Online Women in Pharma infographic.
-
News CPHI Pharma Awards 2026: Recognising Excellence in an Evolving Industry
Submissions now open — deadline May 16
-
News Dr Reddy's to launch generic semaglutide in India
Dr Reddy’s Laboratories, one of India’s leading pharmaceutical companies, is preparing to launch a generic version of semaglutide, branded as Obeda, in March. Obeda is expected to provide a more affordable alternative to Ozempic a... -
News Frontier Biotech and GSK Forge RNA Therapy Partnership
Frontier Biotechnologies and GSK have entered a global licensing agreement to advance small interfering RNA (siRNA) therapeutics. This collaboration grants GSK exclusive rights to develop and commercialise two promising siRNA candidates, marking a mile...