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BioWorld - Thursday, February 5, 2026
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Home » 10 years on, US biosimilars staring down the void
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10 years on, US biosimilars staring down the void

Nov. 25, 2025
By Mari Serebrov
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It’s been a decade since Sandoz Inc. launched Zarxio, referencing Amgen Inc.’s Neupogen (filgrastim), as the first biosimilar in the U.S. Zarxio was expected to be the beginning of a biosimilar boom that would deliver big savings by finally providing direct competition for costly biologics. Neither the pipeline nor the uptake of biosimilars has lived up to expectations, as only 6% of the 313 biologics approved by the FDA’s CDER have been targeted by biosimilars and fewer than 5% are actually competing with the follow-ons.
BioWorld Analysis and data insight Biosimilar U.S. FDA Policy

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