FDA approves Amgen’s interchangeable biosimilar Bkemv

The US Food and Drug Administration (FDA) has given the green light to Amgen’s Bkemv (eculizumab-aeeb), marking it as the first interchangeable biosimilar to Soliris (eculizumab) for the management of certain uncommon diseases. Specifically, Bkemv is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and atypical hemolytic uremic syndrome (aHUS) to prevent complement-mediated thrombotic microangiopathy.

Functioning as a monoclonal antibody, Bkemv targets and binds to the complement C5 protein. This action helps prevent the destruction of red blood cells in patients suffering from PNH and aHUS. In line with Soliris, Bkemv also comes with a boxed warning about the heightened risk of serious meningococcal infections caused by Neisseria meningitidis bacteria. Consequently, it is mandatory for patients to receive meningococcal vaccination before beginning treatment with Bkemv and to be monitored for early indications of infection.

As an interchangeable biosimilar, Bkemv has been rigorously evaluated and confirmed to exhibit no clinically significant differences from Soliris. The biosimilar comes with the same safety warnings and expects similar adverse reactions. During clinical trials for PNH and aHUS, the most commonly reported side effects for Soliris included headaches and nausea.

Sarah Yim, director of the FDA Center for Drug Evaluation and Research Office of Therapeutic Biologics and Biosimilars, emphasized the importance of such approvals: “Many rare conditions are life-threatening and lack treatments. The FDA is committed to facilitating the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited.”

An interchangeable biosimilar, as defined by the FDA, meets additional legal requirements, allowing it to be substituted for the reference product without the need for prescriber consultation. This designation aims to increase accessibility and potentially reduce healthcare costs by offering more treatment options.

Separately, Amgen recently announced that the US FDA granted accelerated approval for IMDELLTRA (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small-cell lung cancer. This approval is part of an ongoing effort to provide faster access to treatments for severe and life-threatening conditions.

In summary, the approval of Bkemv represents a significant milestone in the treatment of rare diseases such as PNH and aHUS, providing patients with another viable option that has been proven to be as safe and effective as the reference drug, Soliris. This aligns with the FDA’s broader mission to enhance the availability of critical therapies for rare and life-threatening conditions.