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 Randomised, Double-blind, Parallel, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) vs. Prolia® (EU-sourced) in Postmenopausal Osteoporosis

Next Previous
Search
Trial Profile

A Randomised, Double-blind, Parallel, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) vs. Prolia® (EU-sourced) in Postmenopausal Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2025

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 Registrational; Therapeutic Use
  • Acronyms SIMBA
  • Sponsors mAbxience

    • Most Recent Events

    • 03 Mar 2025 According to an Amneal Pharmaceuticals Inc. media release, company (longstanding and productive partnership with mAbxienceto advance biosimilars) announced, U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia and XGEVA. The FDA has assigned a target action date in the fourth quarter of 2025.
    • 08 Jul 2024 Status changed from active, no longer recruiting to completed.
    • 20 Jun 2024 This trial has been completed in Hungary, according to European Clinical Trials Database record.

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