Rare Blood Disorder Treatments
Lifetime Administration Increases Patient Burden
Amgen's 'Bekemv' and Others Expected to Compete
Samsung Bioepis has succeeded in developing a biosimilar (biopharmaceutical generic) of Soliris (active ingredient eculizumab), a high-cost rare disease treatment with an annual medication cost reaching 400 million KRW.
On the 30th, Samsung Bioepis announced that it had finally obtained marketing authorization from the European Commission (EC) for the Soliris biosimilar 'Epyscyli (Epysqli, development code SB12).' This final approval came two months after receiving a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on March 30. In South Korea, the company applied for marketing authorization from the Ministry of Food and Drug Safety last July and is currently undergoing the approval process.
Epyscyli became Samsung Bioepis's seventh biosimilar approved in the European market and the first biosimilar approved in the field of hematologic disease treatments. This approval allows the company to diversify its business portfolio from existing autoimmune, oncology, and ophthalmology treatments to include hematologic diseases.
Soliris is a treatment for rare and intractable hematologic diseases developed by the U.S. company Alexion. Its main indication is paroxysmal nocturnal hemoglobinuria (PNH), which is caused by the destruction of red blood cells in the blood, and it is also used for atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG). Soliris grew into a blockbuster drug with global sales reaching $3.762 billion (approximately 5 trillion KRW) last year. Noticing this growth, AstraZeneca acquired Alexion in 2020 through a large-scale merger and acquisition (M&A) deal worth $39 billion (approximately 52 trillion KRW).
The only current cure for PNH is bone marrow transplantation. Soliris is a drug that prevents the disease from worsening, so patients must continue to receive the medication. Given the annual treatment cost of 400 million KRW, the financial burden on patients has been significant. Typically, biosimilars are priced about 30-40% lower than the original drugs, so the launch of biosimilars like Epyscyli is expected to greatly reduce the cost burden for patients with this disease. Samsung Bioepis also provided extended supply by offering Epyscyli free of charge for up to two years to patients participating in clinical trials, considering the financial burden on patients.
Professor Junho Jang, principal investigator (PI) of the Phase 3 clinical trial for Epyscyli (SB12) and a hematology-oncology specialist at Samsung Medical Center, stated, “Epyscyli has demonstrated equivalence through comparative clinical trials with the original drug. We expect it to improve patient access to ultra-high-cost drugs and contribute to addressing unmet needs.” A Samsung Bioepis representative said, “We will strive to provide treatment opportunities to more patients with rare disease biosimilars and contribute to reducing national healthcare expenditures.”
Meanwhile, Epyscyli is expected to engage in fierce competition with Amgen’s 'Bekemv (development code ABP959),' which received EMA approval around the 15th. Although Bekemv completed its Phase 3 clinical trial about nine months later than Epyscyli, which finished in October 2021, it accelerated the approval process afterward and secured the title of 'the first Soliris biosimilar.'
Meanwhile, the original developer Alexion is defending its market share with 'Ultomiris' (active ingredient ravulizumab), which offers greater convenience and lower cost amid the imminent launch of biosimilars. Although the per-dose price is higher, Ultomiris has a significantly longer dosing interval of 8 weeks compared to Soliris’s 2 weeks, resulting in an annual medication cost approximately 30% lower than Soliris. Consequently, Ultomiris is rapidly replacing Soliris, recording annual sales growth of 30-50%.
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