Bkemv and Epysqli, Two Biosimilars of Soliris, are Now Available

Amgen’s Bkemv and Teva/Samsung Bioepis’ Epysqli, biosimilars of Soliris (eculizumab), have launched at a discount to the reference product. Both biosimilars are approved to treat patients with several rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis in adults.

Soliris, a product of Alexion, an AstraZeneca company, is also indicated to treat patients with neuromyelitis optica spectrum disorder, a rare inflammatory disease that affects the optical nerves and spinal cord. The cost for Soliris intravenous solution is $6,523 for a single-dose vial.

The price of Bkemv (eculizumab-aeeb), the first Soliris biosimilar to be approved, is $5,870.70 for a single-dose vial, about 10% below Soliris’ price. It was approved by the FDA in May 2024 and is interchangeable with the reference product.

An Amgen spokesperson emphasized the interchangeability of Bkemv, saying it is the only interchangeable biosimilar for rare diseases approved in the United States. “The success of biosimilars will provide patients, physicians and payers with a range of treatment options and greater flexibility of choice, as well as the potential for meaningful cost savings to healthcare systems,” the spokesperson said.

Related: FDA Approves Second Biosimilar of Soliris

Epysqli has launched a price of $4,566.00 for a single dose, which is a 30% discount off the wholesale acquisition cost of Soliris. The FDA approved Epysqli in July 2024, and the agency has provisionally determined that Epysqli will be interchangeable with the reference biologic Soliris following the expiration of exclusivity for the first interchangeable biosimilar. Epysqli was developed by Samsung Bioepis, and in January 2025, the company entered into an agreement for Teva to be responsible for U.S. commercialization.

A Teva spokesperson said the company anticipates Epysqli will be an attractive option for payers. “Teva is committed to helping patients gain affordable access to our medicines. For decades, we’ve offered assistance programs to improve patient access to our medicines and to help remove barriers to treatment. Eligible patients may receive their medication at no cost or may be eligible for assistance through our programs,” the spokesperson said.

PNH is an ultra-rare blood disorder that is characterized by the destruction of red blood cells. PNH occurs when the complement system — a part of the body’s immune system — over-responds, leading the body to attack its own red blood cells. Atypical hemolytic uremic syndrome is a rare genetic disease in which tiny blood clots form in blood vessels and block blood flow. It can lead to kidney failure and heart disease.

Generalized myasthenia gravis is a chronic autoimmune disorder in which antibodies destroy the communication between nerves and muscles.

Soliris and the biosimilars are C5 complement inhibitors, binding to a protein in the blood that prevents it from breaking apart into other proteins that destroy red blood cells. And like Soliris, the biosimilars have a boxed warning about the increased risk of serious and life-threatening meningococcal infections caused by Neisseria meningitidis, the bacteria that causes meningitis and other severe infections.

Bkemv was approved based on a comparative clinical study in patients with PNH who were stable on eculizumab and found no clinically meaningful differences in efficacy, safety and clinical pharmacology, including immunogenicity profile, between Bkemv and Soliris.

Amgen had presented data at the annual meeting of the American Society of Hematology in December 2023. The study compared Amgen’s biosimilar with Soliris in a crossover study in which 42 patients were enrolled. Efficacy was based on a comparison of hemolysis. The study demonstrated similarity in clinical efficacy in both parallel and crossover comparisons in patients with PNH.

For Epysqli, the FDA’s approval was based on the totality of the evidence, including analytical, nonclinical and clinical data demonstrating it is highly similar to Soliris, with no clinically meaningful differences between Epysqli and Soliris in terms of safety, purity and potency, according to a news release from Samsung Bioepis. A phase 3 crossover study in patients with PNH clinical equivalence in efficacy, safety, pharmacokinetics, and immunogenicity between Epysqli and Soliris.