Samsung Bioepis launches Soliris biosimilar in US through Teva

Samsung Bioepis said it has launched its rare disease treatment Epysqli, a biosimilar referencing Soliris, in the U.S. through its commercial partner Teva Pharmaceuticals.

Samsung Bioepis signed a commercialization partnership agreement with Teva in January this year for the U.S. market entry of Epysqli.

Epysqli is a biosimilar referencing Soliris, a blockbuster biologic originally developed by Alexion Pharmaceuticals. Soliris is indicated for the treatment of several rare and life-threatening disorders, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG).

Soliris recorded global sales of approximately $2.58 billion last year, of which U.S. sales accounted for around $1.52 billion. Known as one of the most expensive biologics on the market, a year-long treatment of Soliris for PNH patients costs an estimated $520,000.

Samsung Bioepis said Epysqli has entered the U.S. market at a wholesale acquisition cost (WAC) that is 30 percent lower than the originator drug.

“Life-threatening diseases such as PNH, aHUS and gMG, if left untreated, can lead to kidney disease, kidney failure or respiratory failure, and it is important for patients to have early access to treatment,” Samsung Bioepis Executive Vice President and Head of Global Commercial Division Linda MacDonald said. “The availability of Epysqli means that patients now have an additional treatment option available at a lower cost, with the proven quality, safety and efficacy comparable to the reference product.”

The company’s mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines, MacDonald added.

MacDonald stressed that Samsung Bioepis will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.

Teva U.S. Biosimilars Senior Vice President and Head Thomas Rainey also said, “Individuals living with rare diseases, including PNH, aHUS and gMG, often have limited access to life-enhancing treatments and we are proud to launch Epysqli in the U.S. as a new, more affordable treatment option to help expand access to these underserved communities.”