pharmaphorum May 29, 2024
The US FDA has approved the first biosimilar version of AstraZeneca/Alexion’s Soliris therapy for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).
The approval positions Amgen’s Bkemv (formerly ABBP 959) as a key competitor to complement C5 inhibitor Soliris (eculizumab), which contributed $3.1 billion in global revenues to AZ last year. However, it is not expected to be launched until March next year in the US under the terms of a settlement in patent litigation between Alexion and Amgen that was agreed in 2020.
It has been cleared with interchangeable status, meaning that pharmacists in the US will be able to substitute the biosimilar for Soliris at the point of dispensing, without consulting the prescriber. So far, 13...
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