FDA okays Amgen's Soliris biosimilar Bkemv for two rare blood diseases
Drug ApprovalPhase 3AcquisitionClinical ResultBiosimilar
The FDA on Tuesday approved Amgen's Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar version of AstraZeneca’s Soliris (eculizumab) for the treatment of two rare blood conditions, paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS).
Bkemv is a C5-targeting monoclonal antibody that inhibits activation of the complement system to prevent intravascular haemolysis in PNH and aHUS. The biosimilar’s FDA clearance, however, does not extend to two other indications of Soliris - generalised myasthenia gravis and neuromyelitis optica spectrum disorder. Amgen’s biosimilar was approved in the EU for PNH last year, where it is marketed as Bekemv.
The FDA noted that Bkemv is highly similar to Soliris, with “no clinically meaningful differences” and a comparable adverse event profile, evidenced by the Phase III DAHLIA study findings in 2022. The agency also stated that the former met other legal requirements to be considered interchangeable with Soliris at the pharmacy level.
The approval of interchangeable biosimilars such as Bkemv “can expand access for individuals with rare diseases whose current treatment options are limited," said Sarah Yim, director of the FDA’s office of therapeutic biologics and biosimilars.
Similar to the reference product, the biosimilar will carry a boxed warning indicating an increased risk of serious and life-threatening meningococcal infections caused by Neisseria meningitidis.
Soliris, acquired by AstraZeneca through the $39-billion takeout of Alexion Pharmaceuticals in 2021, is set to lose its US exclusivity in 2025, under a patent settlement between Alexion and Amgen. The biologic generated nearly $3.15 billion in global sales last year.
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