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Fresenius Kabi

Biosimilar developer, Germany. 5 development products across 5 molecules: adalimumab, denosumab, enoxaparin sodium, pegfilgrastim, tocilizumab.

First approval in the Atlas: Apr 2019, Idacio, adalimumab (EMA)
FDAproducts approved4
EMAproducts approved4
MHRAproducts approved3
PMDAproducts approved0
HCproducts approved3
CDSCOproducts approved0
EDEproducts registered1
Connections
5molecules5products5 of 7markets0candidates in trials8companies on the same molecules

About Fresenius Kabi

Fresenius Kabi, a German hospital products company, has built a biosimilar range of five molecules. Its adalimumab, Idacio, came from Merck KGaA. Its pegfilgrastim, Stimufend, opened its US business in 2022, and its tocilizumab, Tyenne, was the first tocilizumab biosimilar in Europe and the first in both forms in the United States. It added denosumab in 2025 and sells its ustekinumab, developed by Formycon, as Otulfi.

Portfolio by market

MoleculeProductFDAEMAMHRAPMDAHCCDSCOEDEMarkets
AdalimumabIdacio MSB11022Dec 2022Apr 2019MHRA·Oct 2020·Mar 20245/7
DenosumabConexxence / Bomyntra FKS518Mar 2025Jul 2025MHRA····3/7
Enoxaparin sodiumElonox····Oct 2022··1/7
PegfilgrastimStimufend MSB11455Sep 2022Mar 2022·····2/7
TocilizumabTyenne MSB11456Mar 2024Sep 2023MHRA·Oct 2024··4/7

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 Fresenius Kabi is the licence holder or applicant in one or more markets.

MoleculeBrandMarketHolder or applicantApprovedDeveloper
UstekinumabOtulfiEMAFresenius Kabi Deutschland GmbHSep 2024Formycon
UstekinumabOtulfiFDAFresenius Kabi USA, LLCSep 2024Formycon
UstekinumabOtulfiHCFresenius Kabi Canada LTDDec 2024Formycon

In development

ClinicalTrials.gov lists one comparative trial sponsored by Fresenius Kabi 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
DenosumabFKS518Fresenius KabiProliaPhase 3Comparative efficacyCompletedJun 2021Aug 2023Conexxence / BomyntraNCT04934072

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 Fresenius Kabi, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.

SandozFour shared molecules: adalimumab, denosumab, enoxaparin sodium, pegfilgrastim10 molecules in its portfolioCelltrionThree shared molecules: adalimumab, denosumab, tocilizumab10 molecules in its portfolioMochida PharmaceuticalThree shared molecules: adalimumab, pegfilgrastim, tocilizumab5 molecules in its portfolioAlvotechTwo shared molecules: adalimumab, denosumab5 molecules in its portfolioBiocon BiologicsTwo shared molecules: denosumab, pegfilgrastim9 molecules in its portfolioCoherus BioSciencesTwo shared molecules: adalimumab, pegfilgrastim2 molecules in its portfolioEnzene BiosciencesTwo shared molecules: adalimumab, denosumab6 molecules in its portfolioGedeon RichterTwo shared molecules: denosumab, tocilizumab4 molecules in its portfolio

Chronology

Compare Fresenius Kabi with other developers on the comparison page.

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Data current to September 2026.