Samsung Bioepis has launched Renflexis (inflixamab-abda) in the United States. The drug is the biosimilar to Janssen’s Remicade and was approved in April for use in treating several autoimmune inflammatory diseases including Crohn’s disease and rheumatoid arthritis. Renflexis is being marketed in the United States by Merck.
This is the second biosimilar version of Remicade, after Inflectra (infliximab-dyyb, Pfizer), which reached the market last year.
Renflexis will have a wholesale acquisition cost of $739.39, which is 35% lower than the current wholesale acquisition price of Remicade, according to a Samsung Bioepis statement. This does not include any discount that may be applied on the products.
Remicade had U.S. sales of $4.8 billion last year, according to Reuters. However, sales in the first six months of this year have fallen 8.2% from last year due to the new competition. Reuters noted that Janssen has sought a U.S. court injunction to Renflexis, arguing that Samsung Bioepis violated three of its patents, but no hearings on the matter have been scheduled.
Infliximab is a tumor necrosis factor and is approved for use against moderate-to-severe adult and pediatric Crohn’s disease, moderate-to-severe ulcerative colitis, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis, active psoriatic arthritis, and chronic severe plaque psoriasis. Patients treated with infliximab products are at increased risk of serious infections and developing lymphoma and other malignancies. Hepatosplenic T-cell lymphoma has occurred with use in young patients with Crohn’s disease or ulcerative colitis.
Contraindications include moderate to severe congestive heart failure.
Renflexis was approved in Europe in 2016 under the name Flixabi.
Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. “Since we were established five years ago, we have strived to bring high-quality treatment options at a lower cost to US patients. RENFLEXIS is our first step in meeting this important commitment,” said Christopher Hansung Ko, President and CEO of Samsung Bioepis in a company statement.