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(LEAD) Celltrion's Remsima SC wins European approval

Welfare/Medicine 09:55 November 26, 2019

(ATTN: ADDS more info in 5-7 paras)
By Kim Han-joo

SEOUL, Nov. 26 (Yonhap) -- South Korean biopharmaceutical firm Celltrion Inc. said Tuesday that its drug Remsima SC for the treatment of autoimmune diseases has won sales approval in Europe.

On Monday (local time), the European Medicines Agency (EMA) gave the green light to Celltrion's application to sell the subcutaneous (SC) version of Remsima, a biosimilar copy of Janssen Biotech, Inc.'s Remicade, according to the company.

Remsima, administered through intravascular injections, is used in the treatment of a number of diseases, from rheumatoid arthritis to Crohn's disease, Celltrion said. The SC version allows patients to conveniently inject it by themselves, unlike the intravenous formulation that requires patients to visit hospitals.

The authorization comes nearly a year after Celltrion sent the application to the EMA.

"The product is the first SC version of the treatment, offering a unique selling point in the global TNF-alpha inhibitor (autoimmune disease therapeutic agent) market" said a company official who asked not to be named.

The development of the SC formulation of Remsima is one of Celltrion's marketing strategies to increase its share of the global TNF-alpha inhibitor market, estimated to be worth 50 trillion won (US$42.6 billion).

Celltrion said it aims to enter the European market by the first half of next year and that of the United States in 2022.

The company said it intends to improve its competitiveness in the European autoimmune disease therapeutic agent market with the existing Remsima and Remsima SC.

Celltrion said it plans to register patents for its autoimmune disease therapeutic antibody biosimilar in over 130 countries.

The company said Remsima SC will be under patent protection over the next 20 years, helping enhance Celltrion's competitiveness in the global autoimmune disease therapeutic agent market.

This photo, provided by Celltrion Inc. on Nov. 26, 2019, shows its biosimilar drug Remsima SC. (PHOTO NOT FOR SALE) (Yonhap)


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