Amgen’s Bkemv (eculizumab-aeeb) has been approved by the US Food and Drug Administration (FDA) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) for two rare diseases characterised by the breakdown of red blood cells.
The monoclonal antibody has been authorised to reduce haemolysis in patients with paroxysmal nocturnal haemoglobinuria (PNH) and to inhibit complement-mediated thrombotic microangiopathy in those with atypical haemolytic uraemic syndrome (aHUS).
Bkemv is designed to bind to the complement C5 protein and inhibit activation of the complement system, part of the body’s immune system, to prevent the breakdown of red blood cells in the bloodstream.
Biosimilars, according to the FDA, are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said: “Many rare conditions are life-threatening, and many do not have treatments.
“The FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited.”
Like Soliris, Bkemv has a boxed warning stating that eculizumab products increase the risk of serious and life-threatening meningococcal infections caused by Neisseria meningitidis.
The FDA outlined that patients should have completed meningococcal vaccination before starting treatment with Bkemv or Soliris, be monitored for early signs and symptoms of meningococcal infections and undergo immediate further evaluation if these signs develop.
The regulator also noted that Bkemv will only be available through a restricted drug safety programme that it can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
The decision comes just two weeks after the FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) to treat extensive-stage small cell lung cancer in adults with disease progression on or after platinum-based chemotherapy.
