Samsung Bioepis scores FDA approval for Soliris biosimilar to treat PNH, aHUS

Samsung Bioepis said it has received approval from the U.S. FDA for Epysqli, a biosimilar referencing Soliris (ingredient: eculizumab).

Soliris is a drug developed by Alexion, a U.S.-based pharmaceutical company, for the treatment of rare intractable diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The drug recorded global sales of approximately $5 trillion last year.

Soliris is known for its high cost, with an annual treatment expense of approximately $600,000 in the U.S., highlighting a significant unmet need in the medical field for such rare disease therapies.

With this latest approval, Samsung Bioepis now has a total of eight biosimilar products approved in the U.S., expanding its treatment areas to include autoimmune diseases, oncology, ophthalmology, and now blood and kidney disorders.

"Receiving approval for a rare disease treatment in the U.S. validates our global R&D capabilities," Samsung Bioepis CEO Ko Han-sung said. "Epysqli is a product that can maximize the social value of biosimilars, and we will continue our efforts to realize this value in the world's largest pharmaceutical market."

The U.S. approval follows Samsung Bioepis launching Epysqli in Europe in July 2023. The company has recently secured contracts with France's largest pharmaceutical procurement group, UniHA, and the Dutch government.

In Korea, Samsung Bioepis has been directly selling Epysqli since April, offering it at 30 percent cheaper price (2.5 million won per vial) compared to the original Soliris (3.6 million won per vial).