This Medicine That Cost '400 Million Won Annually' Now Sells at Half Price

A biosimilar of Soliris, a high-cost treatment for rare and intractable blood diseases that requires lifelong injections costing 400 million KRW annually, has been launched for the first time in Korea. While proving equivalence, the drug price has been significantly reduced, greatly alleviating the burden on patients.

Samsung Bioepis's treatment for intractable rare blood disorders, 'Episcle'
Photo by Samsung Bioepis

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On the 1st, Samsung Bioepis announced the domestic launch of Episcleer, a biosimilar developed for Soliris. As the first biosimilar launched in Korea, it is expected to significantly reduce the burden on patients who had to bear the high cost of the drug until now.

Soliris is a treatment for rare and intractable blood diseases developed by Alexion in the United States. Its main indication is paroxysmal nocturnal hemoglobinuria (PNH), and it is also used for atypical hemolytic uremic syndrome and systemic severe myasthenia gravis. It is a blockbuster drug that recorded global sales of $3.145 billion (approximately 4.24 trillion KRW) last year. Noticing this growth, AstraZeneca acquired Alexion in 2020 for $39 billion (approximately 52 trillion KRW).

PNH is a disease caused by the destruction of red blood cells in the blood. It shows symptoms of hemoglobinuria and can cause complications such as acute renal failure, which can be fatal, making it a rare disease. However, the only current cure for PNH is bone marrow transplantation. Soliris is a drug that prevents the disease from worsening, so continuous administration is required. Accordingly, the annual treatment cost reaches about 400 million KRW domestically, imposing a heavy financial burden on patients.

In particular, for patients with PNH and atypical hemolytic uremic syndrome, when receiving Soliris, health insurance coverage applies, and under this, the 'out-of-pocket maximum payment system' reduces household burdens caused by excessive medical expenses, limiting the annual patient burden to a maximum of 10.5 million KRW as of this year. However, patients must obtain prior approval for new use from the Health Insurance Review and Assessment Service, and many requests are rejected, so the burden on patients remains significant.

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To address this unmet need, Samsung Bioepis launched Episcleer at a price of 2,514,858 KRW per vial, about half the original drug price of 5,132,364 KRW per vial. Patients switching to Episcleer will see their annual medication costs reduced to around 200 million KRW. This also led to a price reduction effect on the original drug. When a biosimilar is launched, the original drug lowers its price to compete. The new price of Soliris has dropped to 3.6 million KRW, a 70% reduction. Samsung Bioepis explained that even compared to the reduced original price, Episcleer still offers about 30% less financial burden.

Samsung Bioepis conducted a global Phase 3 clinical trial targeting PNH patients from August 2019 to October 2021. Since then, considering patients' drug cost burdens, the company has actively supported treatment for domestic patients. Patients participating in the clinical trial were provided the product free of charge for up to two years, and treatment support was also provided for patients who underwent separate review after obtaining approval for therapeutic use of the investigational drug. Even after launch, a support program for Episcleer-prescribed patients is planned.

Samsung Bioepis obtained domestic marketing authorization for Episcleer in January and succeeded in launching the product within three months after price review and approval by authorities. Samsung Bioepis directly handles domestic distribution and sales. Last year, Samsung Bioepis began direct sales of Episcleer in Europe through its local subsidiary, marking its first direct sales. In Korea, from this year, it is also directly selling three autoimmune disease treatments: Etoloche, Remaroche, and Adaloche.

Go Han-seung, CEO of Samsung Bioepis, emphasized, “We have maximized the business value of biosimilars by prescribing high-quality biopharmaceuticals at affordable prices to more patients,” and added, “We expect to significantly reduce patients’ treatment costs in the future and contribute to saving national health insurance finances.”

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