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FDA Approves Biosim for Two Rare Diseases – Bkem

Last week the FDA approved yet another biosimilar…… oh wait…. it was a biosimilar with an indication for not one, but TWO rare diseases. That makes yet another announcement of a new biosimilar a lot more interesting. 

The FDA approved Bkemv (eculizumab-aeeb), from Amgen, as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases with the same indicates as the reference product—–

  • the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and 
  • the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Bkemv is an infused therapy.

Bkemv also carries a Black Box warning for serious meningococcal infections.

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.

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 (intravascular hemolysis) in patients with PNH and aHUS.

Under a 2020 settlement between the companies, Amgen will be free to launch its version March 1, 2025.

Amgen is not expected to release the price of Bekmv till launch time in 2025. By comparison, Soliris generally cost about $678,000 per year for the average patient. It will be interesting to see the competitive price.

Amgen did not disclose plans for distribution at this time.

CLICK HERE to access prescribing information

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FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

May 28, 2024

CLICK HERE to access the press release

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