Israeli drugmaker Teva Pharmaceutical has teamed up with South Korea-based Samsung Bioepis to license, develop and commercialise Epysqli (eculizumab-aagh) in the US.
Epysqli is a biosimilar to Samsung Bioepis’ rare disease treatment Soliris (eculizumab).
Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, manufacture, and supply of the product.
Teva will be responsible for commercialisation of the product in the US.
Epysqli is indicated for adults with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome (aHUS) and generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.
The drug is not indicated for the treatment of patients with Shiga toxin E. coli-related haemolytic uremic syndrome (STEC-HUS).
Samsung Bioepis president and CEO Kyung-Ah Kim said: “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.
“This collaboration is a testament of our long-term commitment in the biosimilars business, as a leading biopharmaceutical company with a mission to innovate access to treatments for healthcare systems, payers, providers, and patients.
“We will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the US.”
Epysqli was approved by the European Commission (EC) in May 2023, and by South Korea’s Ministry of Food and Drug Safety (MFDS) in January 2024, as a biosimilar to Soliris.
In July last year, the US Food and Drug Administration (FDA) approved Epysqli as a biosimilar to Soliris, to treat patients with PNH and aHUS to inhibit thrombotic microangiopathy.
In November, the US health regulator expanded its indication to include the treatment of adult patients with AchR antibody-positive generalised myasthenia gravis (gMG).
With the first biosimilar launched in 2015, Samsung Bioepis currently offers nine biosimilars covering immunology, oncology, ophthalmology, haematology, and nephrology.
Teva said the partnership with Samsung Bioepis will expand its portfolio of biosimilars to 18 assets across multiple therapeutic areas.
Teva US commercial executive vice president Chris Fox 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 us to leverage our 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.”
