Samsung's blood cell biosimilar approved for sale in Korea

Epysqli, a Samsung Bioepis biosimilar referencing blood cell medicine Soliris, has been approved for sale in Korea, the company said Monday.

A Samsung Bioepis employee conducts tests at its lab in Incheon. [SAMSUNG BIOEPIS]

Epysqli, a Samsung Bioepis biosimilar referencing blood cell medicine Soliris, has been approved for sale in Korea, the company said Monday.

The green light came about eight months after it won approval in Europe.

Epysqli is an identical copy of Eculizumab, better known as Soliris, the name it is marketed under by Boston-based Alexion Pharmaceuticals. It is used to treat paroxysmal nocturnal hemoglobinuria, which destroys red blood cells and can eventually lead to acute renal failure.

It is also considered one of the most expensive biopharmaceuticals, costing patients hundreds of millions of dollars. Samsung Bioepis is the only Korean company to win approval for the product.

Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on evidence that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or efficacy from the reference product, but they cost less.

Samsung Bioepis has a total of 10 biosimilar products and candidates.

BY SARAH CHEA [chea.sarah@joongang.co.kr]