Celltrion Pharm, Uplima Domestic Sales Launch

Celltrion biosimilar (biopharmaceutical generic) 'Yuflyma' 40mg/0.4ml

[Asia Economy Reporter Lee Chun-hee] Celltrion Pharm's autoimmune disease treatment biosimilar (biopharmaceutical generic) 'Yuflyma' (generic name 'adalimumab') is starting sales in South Korea.

Celltrion Pharm announced on the 2nd that Yuflyma will officially begin domestic sales procedures following the announcement of its insurance price. After receiving product approval from the Ministry of Food and Drug Safety last October and the Ministry of Health and Welfare's announcement of the drug reimbursement ceiling price, National Health Insurance coverage began on the 1st.

Yuflyma has already been sold in Europe since receiving product approval from the European Medicines Agency (EMA) in February last year. It is the world's first high-concentration Humira biosimilar approved by the EMA, authorized for all indications held by Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS). In particular, unlike existing low-concentration Humira biosimilars, Yuflyma is developed as a high-concentration formulation that halves the injection volume and removes citrate, which can cause pain, thus offering differentiated product value.

The domestically launched product is 'Yuflyma Pen 40mg/0.4ml,' with a single dose price of 244,877 KRW. When applying the 10% special calculation exception for patients diagnosed with cancer, rare diseases, or severe intractable diseases, the patient’s out-of-pocket cost is 24,488 KRW.

Meanwhile, to commemorate the launch of Yuflyma, Celltrion Pharm is conducting the symposium '2022 Yuflyma & Remsima SC,' sharing the latest data on autoimmune disease treatments by indication. Last month, a symposium was held for rheumatology specialists, and on the 11th and 12th, a two-day symposium will be held for gastroenterology specialists.

The symposium features participation from domestic and international medical professionals, covering topics such as ▲clinical benefits of adalimumab-based autoimmune disease treatments and ▲analysis of actual prescription cases of Remsima SC. Notably, Edward Keystone, professor at the University of Toronto Faculty of Medicine in Canada, presented key results from the global Phase 3 clinical trial of Yuflyma related to rheumatic diseases, and Professor Yoram Bujnik from the Vaugirard Hospital in France introduced clinical data and real European prescription cases of Yuflyma related to inflammatory bowel disease.

A Celltrion Pharm official stated, “With Yuflyma entering full-scale sales procedures, we have established a solid product portfolio in the domestic autoimmune disease treatment market alongside the existing Remsima product line. We will pay close attention to all factors expanding accessibility, including treatment supply, to quickly establish Yuflyma as a new treatment option that meets the needs of medical professionals and patients.”

This content was produced with the assistance of AI translation services.