Development and validation of a method for quantitation of CTx-1 for the assessment of biosimilarity of FKS518, a denosumab biosimilar.

Fresenius Kabi has developed FKS518, a fully human monoclonal antibody biosimilar to denosumab. The clinical development program included two randomized comparative trials: a PK study in healthy volunteers and a safety and efficacy study in osteoporo…

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