Samsung Bioepis Launches Rare Disease Treatment 'Episcle' in the US

Striving to Lead the U.S. Market
with a 30% Reduction in Wholesale Price

Samsung Bioepis Episcle. Photo by Samsung Bioepis

Samsung Bioepis announced on the 8th that it has launched the rare disease treatment 'Episcle' (generic name Eculizumab) in the United States through its marketing partner, Teva.

Episcle is a biosimilar of Soliris. Soliris is a rare disease treatment developed by Alexion in the United States, used for treating rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.

Episcle was launched at a price 30% lower than the wholesale acquisition cost (WAC) of the original drug Soliris, and it is expected to provide cost-saving effects in the U.S.

Last year, the global sales of Soliris reached approximately 3.8 trillion KRW (about 2.588 billion USD), with U.S. sales accounting for about 2.2 trillion KRW (about 1.523 billion USD).

Soliris is a representative ultra-high-priced biopharmaceutical with significant unmet needs in the medical field. The annual treatment cost for paroxysmal nocturnal hemoglobinuria in the U.S. is known to be about 520,000 USD (approximately 760 million KRW).

Samsung Bioepis Headquarters. Photo by Samsung Bioepis

Linda Choi, Vice President and Head of Commercial at Samsung Bioepis, said, "The launch of Episcle is expected to play an important role in expanding treatment options for patients suffering from rare diseases in the U.S. We will continue to strive for a sustainable healthcare system by providing reasonably priced biopharmaceuticals with confirmed quality, safety, and efficacy, and actively cooperate with our partner Teva to achieve this."

Thomas Rainey, Senior Director of Teva's U.S. Biosimilars Division, stated, "Access to medicines is very limited for patients with rare diseases. Through the launch of Episcle, we aim to expand treatment accessibility for rare disease patients and broaden our biosimilar portfolio."

Meanwhile, Samsung Bioepis signed a commercialization partnership agreement with Teva in January for the U.S. market entry of Episcle and is supplying Episcle directly to medical sites through direct sales systems in Europe and Korea. It was launched in Europe in July 2023 and has achieved market leadership in the biosimilar markets of Germany and Italy, as well as winning bids from France's largest purchasing consortium (UniHA) and the Dutch provincial government.

In Korea, the product was launched in April last year at about half the price of the existing original drug, and efforts are being made to improve patient access to ultra-high-priced biopharmaceuticals and contribute to reducing national healthcare expenditures.