Samsung Bioepis launches Epysqli in the US

A rare disease treatment

Entered the US market through Teva... Makes efforts to preemptively occupy the market by reducing wholesale prices by 30%

Targets the KRW 2.2 trillion US market, supplies through a direct sales system in Europe and South Korea

Pic of Epysqli

Samsung Bioepis (CEO Kyung-ah Kim) announced on the 8th that it has launched Epysqli (project name SB12, ingredient name eculizumab), a treatment for rare diseases, in the US through its marketing partner, Teva.

 

Epysqli is a biosimilar version of Soliris.

 

Soliris is a treatment for rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) developed by Alexion in the United States.

 

Soliris is a representative ultra-high-priced biopharmaceutical with a large unmet need in the medical field, and the annual treatment cost for PNH in the United States amounts to USD 520,000 (about KRW 760 million).

 

Last year, global sales amounted to approximately KRW 3.8 trillion (USD 2.588 billion), of which approximately KRW 2.2 trillion (USD 1.523 billion) was from sales in the United States.

 

Epysqli was launched at a 30% discounted price to the wholesale acquisition cost (WAC) of the original drug, Soliris, and is expected to save treatment costs in the United States.

 

“The launch of Epysqli is expected to play an important role in expanding treatment options for patients suffering from rare diseases in the United States,” said Linda Y.

 

MacDonald, Vice President and Head of the Global Commercial Division at Samsung Bioepis.

 

”We will continue to work towards establishing a sustainable healthcare system by providing affordable biopharmaceuticals with proven quality, safety, and efficacy.” Thomas Rainey, Senior Vice President of US Biosimilars at Teva, said, “Access to medicines is very limited for patients with rare diseases.

 

Through the launch of Epysqli, we plan to expand access to treatment for patients with rare diseases while expanding our biosimilar portfolio.” Meanwhile, Samsung Bioepis signed a commercialization partnership agreement with Teva in January to enter the US market and is supplying Epysqli to medical sites through a direct sales system in Europe and South Korea.

 

In Europe, it was launched in July 2023 and has achieved the top market share in the biosimilar market in Germany and Italy, and secured contracts with the largest procurement group in France (UniHA) and the Dutch government.

 

In Korea, it launched the product in April last year at about half the price of the original drug and is working to increase patient access to ultra-high priced biopharmaceuticals and contribute to saving national finances.