[Courtesy of Celltrion]
SEOUL -- U.S. regulators have allowed South Korea's top biosimilar firm Celltrion to conduct only the last stage of clinical trials for Remsima SC, the subcutaneous injection of Remsima, a copy of Janssen Biotech's Remicade treating rheumatoid arthritis and Crohn's disease.
Celltrion said Monday that Remsima SC has applied for the U.S. Food and Drug Administration's investigational new drug (IND). The company, which was allowed to skip phase 1 and 2 trials, plans to win FDA approval in 2022 after completing clinical trials for patients with inflammatory bowel disease in the U.S.
In December last year, Remsima SC applied for approval by the European Medicines Agency. Instead of an intravenous injection that takes more than two hours in hospital, patients can inject Remsima SC into the fat layer beneath the skin at home to enhance patient convenience and access to medical care.
Celltrion's biosimilars include Herzuma, based on Herceptin developed by Genentech, a subsidiary of Swiss pharmaceutical giant Roche. Truxima, the first biosimilar to Rituxan (rituximab), treats patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.
Celltrion Chairman Seo Jung-jin has unveiled an ambitious project to nurture his company as one of the world's three major biotech firms through active expansion. The company plans to set up a joint venture deal with Tasly, a Chinese pharmaceutical company, in the first half of this year.
reporter
Lim Chang-won
cwlim34@ajunews.com
