Samsung Bioepis said it signed a commercialization partnership agreement with Teva Pharmaceutical Industries for the U.S. market entry of Epysqli, a biosimilar referencing Soliris.

Under the agreement, Samsung Bioepis will oversee the production and supply of Epysqli, while Teva will handle marketing and sales activities in the U.S.

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.

Samsung Bioepis received approval for Epysqli from the U.S. FDA in July 2024 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In November 2024, the FDA expanded Epysqli’s indications to include generalized myasthenia gravis (gMG).

Samsung Bioepis had also previously reached a settlement with Alexion, ending their patent dispute over Soliris in the U.S and clearing a path for the launch of Epysqli in the U.S. market in September 2024.

“We are excited to announce this new strategic partnership for a biosimilar which has a significant potential to increase access for rare disease patients, who are suffering from the high-cost and the limited availability of the treatment,” Samsung Bioepis CEO Kim Kyung-ah said. “Rare diseases such as PNH, aHUS and gMG, pose many but unique challenges to patients and their families, and we are dedicated to enhancing the lives of patients including those with rare diseases.”

Samsung Bioepis will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the U.S., she added.

Teva U.S. Commercial Executive Vice President Chris Fox also said, “We are excited to enter this partnership with Samsung Bioepis, who share our commitment to accelerate the delivery of impactful and accessible medicines to patients.”

The collaboration enables Teva to leverage its extensive commercial capabilities and is aligned with our Pivot to Growth strategy, introducing a new biosimilar to our broad biosimilar portfolio, accelerating access to affordable treatment options, Fox added.