Teva gains US marketing rights for Soliris biosimilar Epysqli
Samsung Bioepis therapy approved last year for use by AHUS, PNH patients
Under a new commercialization agreement with Samsung Bioepis, the developer of Epysqli (eculizumab-aagh), Teva Pharmaceuticals will have exclusive marketing rights in the U.S. for the Soliris (eculizumab) biosimilar — an approved treatment for atypical hemolytic uremic syndrome (aHUS).
A biosimilar is a biological product that is highly similar to an already approved biological medicine. It has no clinically meaningful differences in terms of safety, purity, or efficacy compared with the original therapy. However, like generic medications, such therapies usually are more affordable.
The U.S. Food and Drug Administration (FDA) approved Epysqli last July as a treatment for both aHUS and paroxysmal nocturnal hemoglobinuria, known as PNH. Both are rare conditions associated with excessive activity of the complement system, a part of the body’s immune defense. More recently, Epysqli was also approved by the FDA for treating generalized myasthenia gravis, an autoimmune disorder also thought to be driven by the excessive activity of the complement system.
Under the terms of the agreement, Samsung Bioepis will remain responsible for the development, regulatory registration, manufacture, and supply of Epysqli. The deal’s financial terms were not disclosed.
“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,” Chris Fox, executive vice president of U.S. commercial at Teva, said in a joint press release from the two companies. “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.”
Marketing rights deal expected to get biosimilar to patients more quickly
According to Kyung-Ah Kim, PhD, Samsung Bioepis’ president and CEO, the company “will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the U.S.”
With its new marketing rights, Teva will be responsible for Epysqli’s commercialization in the country.
“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,” Kim said.
Soliris — originally developed by Alexion Pharmaceuticals and later acquired by Astrazeneca — is an antibody-based therapy approved in the U.S. since 2011. Its active component, eculizumab, blocks complement activation by targeting a complement protein called C5.
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 … treatment.
Epysqli’s approval in the U.S. was based on data from both preclinical and clinical studies, including a Phase 1 trial (NCT03722329) in healthy volunteers and a Phase 3 trial (NCT04058158) in patients with PNH. In PNH, the overactivation of the complement system leads to the destruction of red blood cells, or hemolysis.
Both studies confirmed that Epysqli matched Soliris in terms of efficacy.
In the Phase 1 study, Epysqli was shown to be comparable to Soliris in safety, and in its immune profile. The biosimilar also was found to have similar pharmacokinetics — how a therapy moves into, through, and out of the body.
During the Phase 3 trial, PNH patients were randomly assigned to receive Epysqli or Soliris at the same dose for 26 weeks, or about six months. This was followed by a switch to the alternate treatment for an equivalent period. Those findings confirmed that Epysqli was therapeutically equivalent to Soliris in reducing hemolysis and minimizing the need for blood transfusions.
“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 … treatment,” Kim said.
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