Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia (EU-authorized)

Next Previous
X
Search
Trial Profile

A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia (EU-authorized)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 May 2024

Price :

$35 *

Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus First in man; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms ROSALIA
  • Sponsors HEXAL; Sandoz

    • Most Recent Events

    • 19 Apr 2024 Results assessing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of biosimilar denosumab GP2411 with reference denosumab published in the Journal of Bone and Mineral Research
    • 25 May 2023 According to a Sandoz media release, the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review. The EMA applications are based on a comprehensive analytical and clinical data package, comprised of data from a Phase I PK/PD similarity study in healthy volunteers and the integrated Phase I/III ROSALIA study.
    • 06 Feb 2023 According to a Sandoz media release, the US Food and Drug Administration (FDA) has accepted Biologics License Application (BLA) for proposed biosimilar denosumab The BLA includes a comprehensive analytical and clinical data package, including data from this trial.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top