Samsung Bioepis has received approval for its Epysqli (eculizumab),’ a biosimilar of the ultra-high-priced rare disease treatment Soliris (eculizumab) in Korea.

At the same time, it was granted first generic exclusivity until October 19th of this year, allowing Samsung Bioepis to market its biosimilar exclusively for the next nine months.

In Korea, Soliris only has a patent for its 'method of treating hemolytic disease' that expires in February 2025, but the Patent Court of Korea cited a ruling by the Intellectual Property Trial and Appeal Board on December 22 last year and ruled IPTAB’s ‘invalidation ruling as legitimate.’

Among eculizumab biosimilars, Epysqli has bec