Celltrion’s Remsima SC drug ready for releaseCelltrion has won approval to sell its rheumatoid arthritis drug Remsima SC in Korea as the company continues growing its presence in the biosimilar market.
The Korean biopharmaceutical company announced Wednesday that the Ministry of Food and Drug Safety approved commercialization of Remsima SC, a subcutaneous version of Celltrion’s infliximab biosimilar Remsima.
Biosimilars are biological pharmaceutical products that are approved based on proof that they are highly similar to a biological product that has already been approved.
The drugs have no clinically meaningful differences in terms of safety or effectiveness from the original product, but they cost less. Remsima is a biosimilar referencing Janssen Biotech’s Remicade.
For the latest approval, Celltrion said that Remsima SC was authorized to treat rheumatoid arthritis. The company plans to win additional approval for Remsima SC to be used as an inflammatory bowel disease treatment before putting the product out on the Korean market.
The company hopes to eventually gain approval to apply Remsima SC as a treatment for all self-immune diseases.
Celltrion views Remsima and its subcutaneous version as highly promising products. The company has indicated interest in boosting its overseas expansion as well as the range of its portfolio.
The subcutaneous version is awaiting approval from the Canadian health authority for Celltrion’s expansion to the North American market.
The drug is also undergoing Phase 3 clinical trials as a novel therapy in the United States, with the goal of earning approval from the U.S. Food and Drug Administration by 2022. The so-called “biobetter” was allowed to skip through the Phase 1 and 2 clinical trials.
Celltrion plans to launch Remsima SC in Germany next month, followed by Britain and the Netherlands during the first half of this year. The product won approval from the European Medicines Agency in November.
The company projects Remsima SC to have 20 percent of the 50 trillion won ($41 billion) global tumor necrosis factor alpha inhibitor market by running a global direct sales system starting with Germany next month.
BY KO JUN-TAE [firstname.lastname@example.org]