Fierce Pharma May 29, 2024
Amgen has made waves in the biosimilar field in recent years with its U.S.-first Humira biosim launch last year and its planned Stelara biosim rollout in 2025. But thanks to a new FDA approval, the company is nearing yet another biosimilar launch.
The FDA has approved Amgen’s Bkemv as the first interchangeable biosimilar to AstraZeneca’s complement inhibitor Soliris (eculizumab). Under a 2020 settlement between the companies, Amgen secured a license to launch its version of eculizumab on March 1, 2025.
AstraZeneca gained Soliris in its $39 billion buyout of Alexion in 2021. The drug’s sales slipped 16% last year as AstraZeneca works to convert patients over to its newer option, Ultomiris.
Still, Soliris represents a sizable target for a...
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