▶FDA ‘신약’ 허가 프로세스로의 진행 권고
▶유럽 주요 5개 국가 인플릭시맙 시장 점유율 10.7%를 기록
▶임상 2건, 안전성·유효성 입증
CELLTRION announced on the 28th that they proved the efficacy and safety of Remsima SC (Project Name, CT-P13 SC), an autoimmune disease treatment, in two out of 3 clinical trials global stage to make inroads in the US market. Based on clinical results, CELLTRION plans to apply for permission from the US Food and Drug Administration (FDA) within the year.
Remsima SC is a product developed with infliximab (as a subcutaneous injection (SC) formulation) which is widely used in the TNF-α (tumor necrosis factor) inhibitor market.
Remsima SC was recognized for the differentiation of its formulation at the approval consultation stage in the US and was recommended to proceed with the 'new drug' approval process by the FDA. Celltrion has been conducting clinical trials for patients with ulcerative colitis and Crohn's disease to launch Remsima SC as a new drug in the United States.
CELLTRION divided 438 patients with Ulcerative Colitis and 343 patients with Crohn's disease into the Remsima SC-administered group and the placebo control group and conducted 3 clinical trials global phase up to 54 weeks respectively. Remsima SC showed significantly higher efficacy results than the placebo control group in two clinical trials. It was confirmed that there was no significant difference in safety compared to the placebo control group.
Remsima SC has already completed patent applications for formulation and administration in about 130 countries around the world and has been sold in Europe since November 2019. As of the second quarter of this year, it recorded a 10.7% share in the infliximab market in five major European countries, including 27% in Germany and 16% in France.
An official of CELLTRION said, "Based on the clinical outcomes, we will proceed with the preparation for FDA approval without a hitch and do our best to settle in the market early by using the fast administration effect and convenience of the formulation"
BK Min, KDFN email@example.com