FDA Approves Amgen’s Soliris Biosimilar

Rare Daily Staff

The U.S. Food and Drug Administration approved Amgen’s Bkemv as the first interchangeable biosimilar to Soliris to treat paroxysmal nocturnal hemoglobinuria patients with atypical hemolytic uremic syndrome.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired blood disorder that primarily manifests in fatigue, and if severe, requires lifelong dependence on blood transfusions. Atypical hemolytic uremic syndrome (aHUS) is a severe and chronic ultra-rare disease that can cause progressive damage to vital organs, predominantly the kidneys, leading to kidney failure and premature death.

Bkemv is a monoclonal antibody that binds to the complement C5 protein and inhibits activation of the complement system, a part of the body’s immune system. This binding prevents the breakdown of red blood cells in the bloodstream in patients with PNH and aHUS.

Bkemv, like Soliris, has a Boxed Warning that states that it can increase the risk of serious and life-threatening meningococcal infections caused by Neisseria meningitidis, the bacteria that causes meningitis and other potentially severe infections. Patients should have completed meningococcal vaccination before starting Bkemv or Soliris, be monitored for early signs and symptoms of meningococcal infections and undergo further evaluation immediately if signs of infection develop.

As an interchangeable biosimilar, Bkemv is highly similar with no clinically meaningful differences to Soliris. Bkemv has the same safety warnings and is expected to have the same adverse reactions as Soliris. The most frequently reported adverse reactions in the PNH randomized trial for Soliris are headache, colds, back pain, and nausea. The most frequently reported adverse reactions in aHUS single arm prospective trials for Soliris are headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, colds, anemia, cough, swelling of lower legs or hands, nausea, urinary tract infections and fever.

Bkemv is the 53rd approved biosimilar in the United States. The FDA has approved 13 of these as interchangeable biosimilars.

Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy (REMS). A REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.