A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis
In women with postmenopausal osteoporosis, RGB-14-P demonstrated equivalent efficacy and pharmacodynamics, and similar immunogenicity and safety to denosumab.
Authors
- Serge Ferrari (ORCID: https://orcid.org/0000-0002-1372-4417)
- Dénes Páll
- Lothar Seefried (ORCID: https://orcid.org/0000-0003-1154-3388)
- Ombretta Viapiana (ORCID: https://orcid.org/0000-0003-1917-5655)
- István Takács (ORCID: https://orcid.org/0000-0002-0847-3844)
- Norbert Jeszenői (ORCID: https://orcid.org/0000-0002-6472-5807)
- J. Rosa (ORCID: https://orcid.org/0000-0001-7807-7751)
- Jeffrey Kiefer (ORCID: https://orcid.org/0000-0002-1238-3120)
- K. Horvát-Karajz
- E. Jókai (ORCID: https://orcid.org/0000-0002-5066-8231)
- Jerzy Supronik
- Rodina Nestorova Licheva
Institutions
- Semmelweis University (HU)
- University of Debrecen (HU)
- University of Würzburg (DE)
- Gedeon Richter (Hungary) (HU)
- Azienda Ospedaliera Universitaria Integrata Verona (IT)
- University Hospital St. Marina (BG)
- University Hospital of Geneva (CH)
- NZOZ Centrum Alergologii (PL)
- Bone Health and Osteoporosis Foundation (US)
Publication Details
- Journal
- Osteoporosis International
- Published
- 2025-10-14
- DOI
- https://doi.org/10.1007/s00198-025-07711-x
- Citations
- 2
- Primary Topic
- Bone health and osteoporosis research
- Type
- article
- Field-Weighted Citation Impact
- 3.44
Funders
- Gedeon Richter