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

2024-05-29

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

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来源: FiercePharma

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.

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 biosimilar company: the drug generated $3.145 billion worldwide last year.

Amgen's biosimilar 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."

"We look forward to bringing Bkemv to market as soon as possible as a potential new option for U.S. patients living with these life-altering diseases," an Amgen spokesperson said.

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

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 Amgen in the biosimilar field. Last year, the company inaugurated the U.S. Humira biosimilar market with its January 2023 launch of Amjevita.

And next year, Amgen is expected to introduce the first U.S. copycat to Johnson & Johnson's immunology blockbuster Stelara. A year ago, Amgen and Johnson & Johnson signed an agreement enabling a Jan. 1, 2025, launch of the California drugmaker's Stelara biosimilar.

Together, Humira, Stelara and Soliris generated tens of billions of dollars at peak, showcasing why biosimilar players are eager to sell copycats to certain biologics.

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

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