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Fresenius Is Latest To File Denosumab With US FDA

While Henlius Confirms EMA Acceptance Of Its European Prolia/Xgeva Biosimilar Filing

 
• By Dave Wallace

With activity around denosumab biosimilars continuing to heat up, Fresenius Kabi has announced US FDA acceptance of its filing, while China’s Henlius says the EMA is reviewing its own biosimilar submission.

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
Fresenius has filed its denosumab biosimilar in the US • Source: Sarah Silbiger/Getty Images (Sarah Silbiger/Getty Images)

Fresenius Kabi has become the latest company to confirm a US Food and Drug Administration filing for a Prolia/Xgeva (denosumab) biosimilar, announcing that its version has now been accepted for review by the US agency.

The firm had reported midway through last year that its FKS518 candidate referencing Prolia (denosumab) successfully met its primary and secondary objectives in a pharmacokinetic similarity clinical trial (see sidebar).

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