Epysqli, biosimilar of PNH treatment Soliris, available in US
Companies say treatment provides lower-cost option for patients
Epysqli (eculizumab-aagh), a Soliris (eculizumab) biosimilar, is now available in the U.S. to reduce red blood cell destruction (hemolysis) in people with paroxysmal nocturnal hemoglobinuria (PNH).
A biosimilar contains an active ingredient that’s highly similar to an approved biological medicine, or reference product, with no clinically meaningful differences in safety, purity, or potency. These medications usually cost less than the original reference therapy, allowing for increased patient access.
Epysqli will be available at a 30% discount to Soliris’ wholesale acquisition cost, according to Samsung Bioepis and Teva, the companies partnering on the PNH treatment.
“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,” Linda MacDonald, executive vice president and head of the global commercial division of Samsung Bioepis, Epysqli’s developer, said in a joint company press release.
The U.S. Food and Drug Administration (FDA) approved Epysqli as a biosimilar last year, a decision supported by preclinical and clinical evidence showing no clinical differences between the therapy and Soliris.
‘More affordable’ PNH treatment
Earlier this year, Samsung Bioepis partnered with Teva to commercialize Epysqli in the U.S. Samsung Bioepis will handle the medicine’s development, manufacturing, and supply, while Teva will be responsible for its sales and marketing.
“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, further expanding our biosimilars medicine portfolio and efforts to deliver important medicines to patients through strategic partnerships that leverage our proven commercialization abilities,” said Thomas Rainey, senior vice president of U.S. Biosimilars at Teva.
Hemolysis in PNH is caused by the abnormal activation of the immune system’s complement cascade. PNH symptoms include anemia (low red blood cell counts), fatigue, shortness of breath, dark-colored urine, and abdominal pain.
Eculizumab, the active ingredient in Soliris and Epysqli, is designed to bind to complement protein C5 and block complement activation, helping to reduce hemolysis and ease PNH symptoms.
Soliris was approved in the U.S. in 2007 for adults with PNH. It’s also approved for other complement-mediated diseases, including atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder.
Epysqli previously received the green light as a Soliris biosimilar in the European Union and in Korea, which now extends to people in the U.S. with PNH, aHUS, and gMG.
“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,” MacDonald said. “We will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.”
In support of its use as a biosimilar, Epysqli was found to have a similar pharmacological profile and comparable safety and tolerability to Soliris in healthy volunteers who participated in a Phase 1 clinical trial (NCT03722329).
Epysqli and Soliris were also equally effective in adults with PNH who had never received a complement inhibitor, a Phase 3 study (NCT04058158) showed. Levels of lactate dehydrogenase, a marker of cell and tissue damage used to assess PNH activity, were similar with both treatments, meeting the study’s primary goal. Also, more than two-thirds of patients on either treatment didn’t need blood transfusions.
Like Soliris, Epysqli’s prescribing information includes a boxed warning about serious meningococcal infections, which are more likely to occur in people treated with complement inhibitors, including therapies containing eculizumab. As a result, Epysqli is only available in the U.S. through a restricted access program called Epysqli REMS.
“Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines,” MacDonald said.
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