Sandoz

Biosimilar developer, Switzerland. 10 development products across 10 molecules: adalimumab, aflibercept, denosumab, enoxaparin sodium, epoetin alfa and zeta, etanercept, filgrastim, pegfilgrastim, rituximab, somatropin.

First approval in the Atlas: Apr 2006, Omnitrope, somatropin (EMA)
FDAproducts approved6
EMAproducts approved9
MHRAproducts approved9
PMDAproducts approved3
HCproducts approved8
CDSCOproducts approved0
EDEproducts registered8

About Sandoz

Sandoz made the first biosimilar ever approved, Omnitrope, in Europe in 2006, and the first approved in the United States, Zarxio, in 2015. Its own portfolio covers ten molecules, and it also sells products developed by others: Formycon's ranibizumab in the United States, Bio-Thera's bevacizumab, Polpharma's natalizumab, Gan & Lee's insulins in Europe and EirGenix's trastuzumab. It has the widest Gulf presence of any company, with eight products registered in the UAE through its partner Alphamed, and three approvals in Japan.

Portfolio by market

MoleculeProductFDAEMAMHRAPMDAHCCDSCOEDEMarkets
AdalimumabHyrimoz / Hefiya GP2017Oct 2018Jul 2018MHRA·Nov 2020·Oct 20195/7
AfliberceptEnzeevu / AfqlirAug 2024Nov 2024MHRA·Oct 2025··4/7
DenosumabJubbonti / Wyost GP2411Mar 2024May 2024MHRA·Feb 2024·Jun 20265/7
Enoxaparin sodiumInclunox····Nov 2020··1/7
Epoetin alfa and zetaBinocrit / Epoetin alfa Hexal / Abseamed HX575·Aug 2007MHRA···Sep 20183/7
EtanerceptErelzi GP2015Aug 2016Jun 2017MHRA·Apr 2017·Apr 20205/7
FilgrastimZarxio / Zarzio EP2006Mar 2015Feb 2009MHRAMar 2014··Mar 20155/7
PegfilgrastimZiextenzo LA-EP2006Nov 2019Nov 2018MHRA·Apr 2020·Oct 20205/7
RituximabRixathon / Riximyo GP2013·Jun 2017MHRASep 2017Apr 2020·Mar 20195/7
SomatropinOmnitrope·Apr 2006MHRAJun 2009Apr 2009·May 20145/7

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 Sandoz is the licence holder or applicant in one or more markets.

MoleculeBrandMarketHolder or applicantApprovedDeveloper
InfliximabZesslyEMASandoz GmbHMay 2018Pfizer and Sandoz
Insulin glargineOndibtaEMASandoz GmbHJan 2026Gan & Lee Pharmaceuticals
NatalizumabTyrukoFDASandoz Inc.Aug 2023Polpharma Biologics
NatalizumabTyrukoEMASandoz GmbHSep 2023Polpharma Biologics
RanibizumabCimerliFDASandoz Inc.Aug 2022Bioeq (Formycon and Polpharma)
TrastuzumabHerwendaEMASandoz GmbHNov 2023EirGenix

In development

ClinicalTrials.gov lists seven comparative trials sponsored by Sandoz for five molecules: adalimumab, denosumab, etanercept, pegfilgrastim, rituximab. All of these candidates already have at least one approval in the seven markets.

MoleculeCandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionIn the AtlasRegistry record
AdalimumabGP2017SandozHumiraPhase 3Comparative efficacyCompletedDec 2013Jul 2015Hyrimoz / HefiyaNCT02016105
DenosumabGP2411SandozProliaPhase 3Comparative efficacyCompletedJul 2019Apr 2022Jubbonti / WyostNCT03974100
EtanerceptGP2015SandozEnbrelPhase 3Comparative efficacyCompletedFeb 2015Dec 2016ErelziNCT02638259
EtanerceptGP2015SandozEnbrelPhase 3Comparative efficacyCompletedJun 2013Jun 2014ErelziNCT01891864
PegfilgrastimLA-EP2006SandozNeulastaPhase 3Comparative efficacyCompletedJun 2012May 2013ZiextenzoNCT01735175
RituximabGP2013SandozMabTheraPhase 3Comparative efficacyCompletedDec 2011Jul 2015Rixathon / RiximyoNCT01419665
RituximabGP2013SandozMabTheraPhase 3Comparative efficacyCompletedJul 2015Jul 2016Rixathon / RiximyoNCT02514772

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

Chronology

Compare Sandoz with other developers on the comparison page.

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Data current to September 2026.