Samsung Bioepis, Teva partner to market Soliris biosimilar in US
Epysqli approved by FDA last year for PNH; cost may be more affordable
Samsung Bioepis has partnered with Teva Pharmaceuticals to commercialize the Soliris (eculizumab) biosimilar Epysqli (eculizumab-aagh) in the U.S. for people with paroxysmal nocturnal hemoglobinuria (PNH).
A biosimilar is a biological product with an active ingredient that is highly similar to an already approved biological medicine, known as the reference product. It has no clinically meaningful differences in safety, purity, or efficacy compared with the original therapy, but is usually more affordable.
“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,” Kyung-Ah Kim, PhD, president and CEO of Samsung Bioepis, said in a joint press release from the two companies.
“We will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the U.S.,” Kim said.
Biosimilar Epysqli, Soliris both have eculizumab as main ingredient
An acquired disease, PNH is caused by the abnormal activation of the immune system’s complement cascade, which leads to hemolysis, or the destruction of red blood cells. This in turn leads to a range of symptoms that can include fatigue, shortness of breath, abdominal pain, and dark-colored urine.
Eculizumab, the active ingredient in Soliris and Epysqli, is designed to block the action of a complement system protein called C5. By doing so, it helps prevent the abnormal activation of the complement cascade, thereby reducing hemolysis and alleviating other PNH symptoms.
Soliris has been approved in the U.S. since 2007 for adults with PNH. It’s also approved for other complement-mediated diseases, including atypical hemolytic uremic syndrome, or aHUS, generalized myasthenia gravis, known as gMG, and neuromyelitis optica spectrum disorder, or NMOSD.
The U.S. Food and Drug Administration (FDA) last year approved Epysqli as a Soliris biosimilar for PNH, as well as for aHUS, and gMG.
The therapy also has been approved as a Soliris biosimilar in Korea, and in the European Union.
“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,” Kim said.
[Teva is] excited to enter this partnership with Samsung Bioepis, who share our commitment to accelerate the delivery of impactful and accessible medicines to patients.
Clinical trials supporting Epysqli’s approval as a biosimilar demonstrated that its safety and efficacy profile was nearly identical to that of Soliris.
A Phase 1 clinical trial (NCT03722329), conducted in Germany, showed that Epysqli and Soliris had similar pharmacological properties and safety in healthy volunteers. A global Phase 3 study (NCT04058158), which directly compared the effects of Epysqli against Soliris in adults with PNH who had never received a complement inhibitor, also demonstrated similar results with the two treatments. That Phase 3 trial evaluated levels of lactate dehydrogenase, a marker of cell and tissue damage often used to assess PNH activity, and the need for blood transfusions among patients.
Under the terms of the new agreement, Samsung Bioepis will be responsible for Epysqli’s development, regulatory registration, manufacture, and supply. Teva, meanwhile, will be responsible for commercializing the therapy in the U.S.
“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,” said Chris Fox, executive vice president of U.S. commercial at Teva.
“The collaboration enables us to leverage our extensive commercial capabilities,” Fox added, noting Teva’s “broad biosimilar portfolio.”
Similar to Soliris, Epysqli’s label includes a boxed warning about serious meningococcal infections, which have been associated with complement inhibitors. Due to the risk of such infections, the therapy is only available in the U.S. through a restricted access program, called Epysqli REMS, which ensures it’s exclusively prescribed by certified healthcare professionals.
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