Epysqli, Soliris biosimilar, now available for aHUS patients in US
List price of new medicine expected to be 30% lower than brand name drug
Epysqli (eculizumab-aagh), a biosimilar of Soliris (eculizumab), is now available for patients in the U.S., according to an announcement from Samsung Bioepis and Teva Pharmaceuticals.
The biosimilar is authorized to treat people with atypical hemolytic uremic syndrome (aHUS), as well as paroxysmal nocturnal hemoglobinuria, and generalized myasthenia gravis — all of which are conditions that Soliris is approved to treat.
Biosimilars are treatments that are highly similar in terms of purity, safety, and efficacy to a brand-name biological medicine, known as the reference product. They’re comparable to generics for traditional medicines.
However, because biological therapies are made using living cells rather than being chemically synthesized, the regulatory requirements and naming conventions for biosimilars are more complex. Similar to generics, biosimilars are typically marketed at a lower price than the reference product.
“Individuals living with rare diseases, including …. atypical hemolytic uremic syndrome … often have limited access to life-enhancing medicines. 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,” Thomas Rainey, senior vice president of U.S. biosimilars at Teva, said in a joint company press release.
Teva, which is marketing Epysqli in the U.S. under an agreement with developer Samsung Bioepis, said that the biosimilar treatment will be available at approximately a 30% reduced list price relative to Soliris. The release calls Epysqli “one of the greatest cost-saving biosimilars to Soliris in the U.S.”
Soliris biosimilar Epysqli only available via restricted access program
Linda MacDonald, executive vice president and head of the global commercial division of Samsung Bioepis, said the company “will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.”
According to MacDonald, “the availability of Epysqli means that patients now have an additional treatment option available at a lower cost, with … proven quality, safety and efficacy comparable to the reference product.”
Soliris is an antibody-based medication that works to block the activation of the complement cascade, a group of immune proteins whose activation helps to drive disease activity in aHUS and other conditions.
For aHUS, the recommended dosing schedule in adults is 900 mg weekly for the first four weeks, then 1,200 mg in the fifth week, and 1,200 mg every other week thereafter. In children and adolescents, dosing is based on body weight. Epysqli is dosed in the same way, as stated in its prescribing information.
The availability of Epysqli means that patients now have an additional treatment option available at a lower cost, with … proven quality, safety and efficacy comparable to the reference product.
Similar to Soliris, Epysqli’s label comes with a boxed warning for serious meningococcal infections. Complement inhibitors and products containing eculizumab, the active agent in both Soliris and Epysqli, are known to increase the risk of such infections. Due to this increased risk, Epysqli is only available in the U.S. through a restricted access program, called Epysqli REMS.
The U.S. Food and Drug Administration approved Epysqli for aHUS last year based on clinical trial data showing that it had similar pharmacological properties to Soliris in healthy volunteers, and that it showed similar efficacy in people with PNH.
About the Author
