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Denosumab biosimilar - Gedeon Richter

Drug Profile

Denosumab biosimilar - Gedeon Richter

Alternative Names: RGB 14-P

Latest Information Update: 28 Dec 2023

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At a glance

  • Originator Gedeon Richter
  • Class Antihypercalcaemics; Antineoplastics; Antirheumatics; Calcium regulators; Immunotherapies; Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; RANK ligand inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Postmenopausal osteoporosis

Most Recent Events

  • 15 Nov 2023 Gedeon Richter completes a phase III trial in Postmenopausal osteoporosis in USA, Ukraine, Spain, Poland, Italy, Hungary, Czech Republic and Bulgaria (SC) (NCT05087030) (EudraCT2020-006017-38)
  • 08 Dec 2021 Gedeon Richter enters into licensing agreement with Hikma Pharmaceuticals to commercialise denosumab biosimilar in USA
  • 05 Aug 2021 Denosumab biosimilar - Gedeon Richter is available for licensing as of 21 Jul 2021. https://www.gedeonrichter.com/en/partnering (Gedeon Richter website, August 2021)
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