Gedeon Richter

Biosimilar developer, Hungary. 4 development products across 4 molecules: denosumab, teriparatide, tocilizumab, ustekinumab.

First approval in the Atlas: Jan 2017, Terrosa, teriparatide (EMA)
FDAproducts approved1
EMAproducts approved4
MHRAproducts approved4
PMDAproducts approved0
HCproducts approved0
CDSCOproducts approved0
EDEproducts registered0

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

MoleculeProductFDAEMAMHRAPMDAHCCDSCOEDEMarkets
DenosumabEnoby / Xtrenbo / Junod / Yaxwer RGB-14Sep 2025Jun 2025MHRA····3/7
TeriparatideTerrosa / Movymia RGB-10·Jan 2017MHRA····2/7
TocilizumabTuyory RGB-19·Apr 2026MHRA····2/7
UstekinumabUsymro·Aug 2025MHRA····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.

MoleculeBrandMarketHolder or applicantApprovedDeveloper
Follitropin alfaBemfolaEMAGedeon Richter Plc.Mar 2014Finox Biotech
Follitropin alfaBemfolaEDEGedeon Richter Plc., HungarySep 2016Finox 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.

MoleculeCandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionIn the AtlasRegistry record
DenosumabRGB-14Gedeon RichterProliaPhase 3Comparative efficacyCompletedSep 2021Oct 2023Enoby / Xtrenbo / Junod / YaxwerNCT05087030

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

Compare Gedeon Richter with other developers on the comparison page.

Considering a partner, a licence or a new market for a biosimilar portfolio? EvySaif's regulatory strategy and value dossier work covers the regulatory and market-access side of that decision.

Planning your biosimilar strategy?

EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.

Talk to a biosimilar regulatory consultant
Data current to September 2026.