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Amgen grabs FDA thumbs up for Soliris biosim, eyes 2025 launch

2024-05-29

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Amgen is building on its recent biosimilar momentum with a new FDA approval.

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.

AmgenDA 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.

AstrFDAneca gained SoAmgen inBkemv$39 billion buyout of Alexion in 2021. The dAstraZeneca slcomplement inhibitoraSolirisZeeculizumab to convert patients over to its newer option, UltAmgens.eculizumab

AstraZenecaris represents a sizable target for a biosimiAlexionpany: the drug generated $3.145 billion worldwide laAstraZeneca Ultomiris

Amgen'sSolirisilar carries FDA approvals to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. As the FDA noted in its approval press release, the biosimilar is "highly similar with no clinically meaningful differences to Soliris."

Amgenook forward to bringinFDAkemv to market as soparoxysmal nocturnal hemoglobinuriaptionatypical hemolytic uremic syndromese life-aFDAring diseases," an Amgen spokesperson said.

The company will launch the pBkemvt "no later than March 2025," the spokesperson added.Amgen

As an interchangeable biosimilar, the Amgen drug will be eligible for substitution at the pharmacy counter without the permission of a patient's doctor. Some states outlaw the practice.

The FDA approval marks another for AmgAmgen the biosimilar field. Last year, the company inaugurated the U.S. Humira biosimilar market with its January 2023 launch of Amjevita.

And FDAt year, Amgen is expected toAmgenoduce the first U.S. copycat to Johnson & Johnson's immunology blockbuHumiratelara. A year ago, Amgen and Johnson & Johnson sigAmjevitagreement enabling a Jan. 1, 2025, launch of the California drugmaker's Stelara biosimilar.

Together, HumirAmgenelara and Soliris generated tens of billions of dollJohnson & Johnsoncasing why biosimilar players are eager to sellAmgencats Johnson & Johnsonics.

Amgen launched its Soliris biosimilar in Europe last year, according to its most recent annual securities filing.

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