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Kabi Makes Progress With Denosumab, Phase III Due To Complete

Sandoz Emerged Earlier This With US, EU Filings, US Lawsuit Followed

 
• By Dean Rudge

Fresenius Kabi has welcomed “another testimonial of our efforts to expand our biosimilar portfolio,” with an update for its FKS518 biosimilar denosumab candidate.

Clinical trial
• Source: Alamy

With filings in major developed markets beginning to emerge for proposed biosimilars to denosumab, Fresenius Kabi is continuing to position itself for the opportunity, reporting that its FKS518 candidate referencing Prolia (denosumab) successfully met its primary and secondary objectives in a pharmacokinetic similarity clinical trial.

The German firm is also continuing with a global Phase III clinical study, LUMIADE-3, “with the aim to compare the efficacy, safety, tolerability, and immunogenicity of FKS518 with the

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