NewsFlash – Soliris Biosimilar, Bkemv, Approved but not Launched

Bkemv^™ (eculizumab-aeeb – Amgen) injection was approved by the U.S. Food and Drug Administration (FDA) on May 28, 2024. A monoclonal antibody that blocks the activity of the immune system protein, complement C5, it is the first biosimilar for Soliris^® (eculizumab – Alexion/AstraZeneca). It was approved to treat the rare inherited conditions paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Bkemv is given as intravenous (IV) infusions. After loading doses, maintenance doses are administered once every two weeks – for adults at 900mg to treat PNH and 1,200mg for aHUS. Doses for pediatric patients depend on their weight. Fully interchangeable with Soliris, Bkemv can be dispensed without contacting the prescriber in states that allow substitution. Like Soliris, Bkemv has a boxed warning and it will be dispensed under a risk evaluation and mitigation strategy (REMS) due to the increased chance that patients using it may be more prone to acquiring meningitis that can be fatal. A settlement agreement delays its launch until March 2025. Pricing and distribution have not yet been announced. Full prescribing information for Bkemv is here.

At a Glance

• Brand (Generic) Name: Bkemv (eculizumab-aeeb)
• Manufacturer: Amgen
• Date Approved: May 28, 2024
• Indications: to reduce hemolysis for patients who have PNH and to inhibit complement-mediated thrombotic microangiopathy for patients who have aHUS
• Dosage Forms Available: single-dose vials of 300mg/30mL
• Launch Date: March 2025
• Estimated Cost: Not yet available
• With an estimated prevalence of 5,000 to 6,000 patients in the U.S., PNH most commonly is diagnosed among people in their 30s or 40s. It makes red blood cells disintegrate, resulting in dark-colored urine. Other symptoms are anemia, blood clots, and fatigue.
• Up to one-half of patients who receive the current standard of therapy for PNH still need blood transfusions and a large percentage have persistent anemia.
• Approximately 600 Americans are estimated to have aHUS, which causes microclots that can result in kidney failure.
• By blocking complement C5, Bkemv lessens the disintegration of red blood cells by the immune system.
• In phase III clinical trials, results for patients using Bkemv were comparable to those of Soliris in both conditions.
• Between 10% and 20% of patients using eculizumab in clinical studies reported a number of adverse effects, including anemia, cough, fever, headaches, high blood pressure, infections, nasopharyngitis, and nausea.
• Two weeks or longer before starting treatment with Bkemv, candidates for its use should be vaccinated against meningococcal bacteria.
• Ultomiris^® (ravulizumab-cwvz) injection, a long-acting C5 complement inhibitor made by AstraZeneca’s Alexion division also is approved to treat both conditions. Its maintenance doses are given once every four weeks or eight weeks.