'Annual 500 Million' Ultra-High-Priced Drug 'Soliris'... Epis Launches Biosimilar Development

As the patent expiration of the high-cost drug Soliris (generic name Eculizumab), which costs 400 to 500 million KRW annually for treatment, approaches, the biosimilar market is also about to open. Samsung Bioepis and Amgen are competing to secure the title of the first biosimilar.

Alexion's paroxysmal nocturnal hemoglobinuria (PNH) treatment 'Soliris'

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According to Samsung Bioepis on the 3rd, 'Epyscyli (Epyscyli, development code SB12)', a biosimilar of Soliris under development, recently received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA). After the final review by the European Commission (EC), which usually takes 2 to 3 months, official marketing authorization is expected. Last July, the company also applied for product approval with the Korea Ministry of Food and Drug Safety and is currently undergoing the process.

Epyscyli is the first product developed by Samsung Bioepis in the hematology field and is expected to be the seventh biosimilar to receive approval. This means the company can diversify its business portfolio to include the hematology field, following existing autoimmune disease, oncology, and ophthalmology treatments.

Soliris is a treatment for rare and intractable blood diseases developed by the U.S. company Alexion. Its main indication is paroxysmal nocturnal hemoglobinuria (PNH), which occurs due to 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). 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 necessary. As a result, the annual treatment cost reaches 400 to 500 million KRW.

Thanks to this situation, Soliris grew into a blockbuster drug with global sales of $3.762 billion (about 5 trillion KRW) last year. This growth is also considered a driving force behind AstraZeneca's $39 billion (about 51 trillion KRW) acquisition of Alexion in 2020.

A Samsung Bioepis official said, "Epyscyli is a drug that can realize the essential meaning of biosimilar development by improving patient access to ultra-high-cost biopharmaceuticals," adding, "We will strive to provide more treatment opportunities to patients suffering from rare diseases." Since biosimilars are generally priced about 30-40% lower than the original drugs, the plan is to significantly reduce patients' cost burden. Samsung Bioepis has also provided extended supply by offering Epyscyli free of charge for up to two years to clinical trial participants, considering patients' drug cost burdens.

Exterior view of Samsung Bioepis building in Songdo, Incheon [Photo by Samsung Bioepis]

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The biggest competitor to Epyscyli is Amgen's 'Bekemv (development code ABP959)'. It completed clinical trials involving 42 subjects in 14 countries including the U.S. and the U.K., and previously received a CHMP approval recommendation. Although Bekemv completed clinical trials about nine months later than Epyscyli, which finished in October 2021, it is moving faster toward approval, intensifying the competition for the title of the first Soliris biosimilar.

The two companies also have different launch strategies. While Amgen has announced a U.S. launch in 2025 through a patent agreement with Alexion, Samsung Bioepis has adopted a fast-move strategy through patent trials. In February, the Korean Intellectual Property Tribunal invalidated the patent on Soliris's hemolytic disease treatment method, giving Samsung Bioepis a favorable position. Since the patent was set to expire in February 2025, obtaining domestic approval could significantly advance the launch timing.

Meanwhile, the original developer Alexion is defending its market share with 'Ultomiris' (generic name Ravulizumab), which offers improved convenience and lower drug costs. Although the per-dose price is higher, the dosing interval is significantly longer at 8 weeks compared to Soliris's 2 weeks, resulting in an annual treatment cost about 30% lower than Soliris. As a result, Ultomiris is reportedly achieving annual sales growth of 30-50%.

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