Gedeon Richter
Biosimilar developer, Hungary. 4 development products across 4 molecules: denosumab, teriparatide, tocilizumab, ustekinumab.
About Gedeon Richter
Gedeon Richter, the Hungarian company best known for women's health medicines, has four biosimilar molecules approved in Europe: teriparatide in 2017, the first in Europe, developed with Richter-Helm; denosumab in 2025, sold in the United States by Hikma; ustekinumab in 2025; and tocilizumab in 2026. It also sells the follitropin biosimilar Bemfola, which it acquired from Finox.
Portfolio by market
| Molecule | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE | Markets |
|---|---|---|---|---|---|---|---|---|---|
| Denosumab | Enoby / Xtrenbo / Junod / Yaxwer RGB-14 | Sep 2025 | Jun 2025 | MHRA | · | · | · | · | 3/7 |
| Teriparatide | Terrosa / Movymia RGB-10 | · | Jan 2017 | MHRA | · | · | · | · | 2/7 |
| Tocilizumab | Tuyory RGB-19 | · | Apr 2026 | MHRA | · | · | · | · | 2/7 |
| Ustekinumab | Usymro | · | Aug 2025 | MHRA | · | · | · | · | 2/7 |
Month shown is the first approval or registration of that product in that market.
Also holds or markets
Products developed by another company for which Gedeon Richter is the licence holder or applicant in one or more markets.
| Molecule | Brand | Market | Holder or applicant | Approved | Developer |
|---|---|---|---|---|---|
| Follitropin alfa | Bemfola | EMA | Gedeon Richter Plc. | Mar 2014 | Finox Biotech |
| Follitropin alfa | Bemfola | EDE | Gedeon Richter Plc., Hungary | Sep 2016 | Finox Biotech |
In development
ClinicalTrials.gov lists one comparative trial sponsored by Gedeon Richter for one molecule: denosumab. All of these candidates already have at least one approval in the seven markets.
| Molecule | Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|---|
| Denosumab | RGB-14 | Gedeon Richter | Prolia | Phase 3 | Comparative efficacy | Completed | Sep 2021 | Oct 2023 | Enoby / Xtrenbo / Junod / Yaxwer | NCT05087030 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026.
Companies on the same molecules
Developers whose portfolios overlap most with Gedeon Richter, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.
Chronology
- EMAJan 2017Terrosa, teriparatide
- EMAJan 2017Movymia, teriparatide
- EMAJun 2025Junod, denosumab
- EMAJun 2025Yaxwer, denosumab
- EMAAug 2025Usymro, ustekinumab
- FDASep 2025Enoby, denosumab
- FDASep 2025Xtrenbo, denosumab
- EMAApr 2026Tuyory, tocilizumab
Compare Gedeon Richter with other developers on the comparison page.
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