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 US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines. -
News Women in Pharma: Manufacturing personal and team success
Our monthly Women in Pharma series highlights the influential lives and works of impactful women working across the pharmaceutical industry, and how the industry can work towards making the healthcare industry and workplace more equitable and inclusive... -
News Pfizer may shift production back to US under Trump pharma tariffs
At the 45th TD Cowen annual healthcare conference in Boston, USA, Pfizer CEO Albert Bourla outlined the potential for Pfizer to shift its overseas drug manufacturing back to the US as pharmaceutical industry players weigh their options against Presiden... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience. -
News Women in Pharma: Connecting accessible pharma packaging to patients – a Pharmapack Special
Throughout our Women in Pharma series, we aim to highlight how CPHI events encourage discussions around diversity, equity, and inclusion initiatives in the pharmaceutical industry. -
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries. -
News Trump administration halts global supply of HIV, malaria, tuberculosis drugs
In various memos circulated to the United States Agency for International Development (USAID), the Trump administration has demanded contractors and partners to immediately stop work in supplying lifesaving drugs for HIV, malaria, and tuberculosis to c... -
News 2024 Drug Approvals: a lexicon of notable drugs and clinical trials
50 drugs received FDA approval in 2024. The centre for biologics evaluation and research also identified six new Orphan drug approvals as under Biologics License Applications (BLAs). The following list picks out key approvals from the list, and highlig...
Recently Visited
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance