US FDA accepts Sandoz Biologics License Application

US FDA accepts Sandoz Biologics License Application

Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA  Sandoz, a global leader in off-patent (generic and biosimilar) medicines, has announced that the US Food and Drug Administration (US FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.  The application includes all indications covered by the reference medicines Prolia® (denosumab) […]

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