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Biosimilars in Canada

Biosimilar biologic drugs with a Notice of Compliance from Health Canada, with DIN owner, DINs and the first approval or market date in the Drug Product Database.

Regulator: Health Canada
HCproducts approved70
HCmolecules with a biosimilar21
HCwithdrawn3

By molecule

Products approved per molecule.

Adalimumab8Denosumab7Bevacizumab6Ustekinumab6Aflibercept5Enoxaparin sodium5Infliximab5Pegfilgrastim5Trastuzumab5Etanercept3Filgrastim3Rituximab3Insulin aspart2Insulin glargine2Ranibizumab2Tocilizumab2Insulin human1Insulin lispro1Omalizumab1Somatropin1Teriparatide1

Every record

MoleculeBrandDeveloperHolder or applicantApprovedDINsStatus
AdalimumabHadlimaSamsung BioepisSamsung Bioepis CO., LTDMay 2018DIN 02473097, 02473100Approved
AdalimumabIdacioFresenius KabiFresenius Kabi Canada LTDOct 2020DIN 02502666, 02502674, 02502682Approved
AdalimumabAmgevitaAmgenAmgen Canada INCNov 2020DIN 02459299, 02459302, 02459310Approved
AdalimumabHyrimozSandozSandoz Canada IncorporatedNov 2020DIN 02492156, 02492164, 02505258, 02542315, 02542323, 02542331, 02542358, 02542366Approved
AdalimumabHulioFujifilm Kyowa Kirin BiologicsBiocon Biologics Canada INCNov 2020DIN 02502380, 02502399, 02502402Approved
AdalimumabAbriladaPfizerPfizer Canada ULCJan 2021DIN 02511045, 02511053, 02511061Approved
AdalimumabYuflymaCelltrionCelltrion INC.Dec 2021DIN 02523760, 02523779, 02535076, 02535084Approved
AdalimumabSimlandiAlvotechJamp Pharma CorporationJan 2022DIN 02523949, 02523957, 02523965Approved
AfliberceptAflivuApotexApotex INCJun 2025DIN 02554178, 02554194Approved
AfliberceptYesafiliBiocon BiologicsBiocon Biologics Canada INCJun 2025DIN 02535858, 02558238Approved
AfliberceptPavbluAmgenAmgen Canada INCJul 2025DIN 02550636Approved
AfliberceptEnzeevuSandozSandoz Canada IncorporatedOct 2025DIN 02562510Approved
AfliberceptEydenzeltCelltrionCelltrion INC.Nov 2025DIN 02563037, 02563045Approved
BevacizumabMvasiAmgenAmgen Canada INCApr 2018DIN 02470748, 02470756Approved
BevacizumabZirabevPfizerPfizer Canada ULCJun 2019DIN 02489430, 02489449Approved
BevacizumabBambeviApotexApotex INCSep 2021DIN 02520729, 02520737Approved
BevacizumabAbevmyBiocon BiologicsBiocon Biologics Canada INCNov 2021DIN 02522160, 02522179Approved
BevacizumabAybintioSamsung BioepisSamsung Bioepis CO., LTDNov 2021DIN 02522829, 02522837Approved
BevacizumabVegzelmaCelltrionCelltrion INC.Jan 2023DIN 02534177, 02534185Approved
DenosumabJubbontiSandozSandoz Canada IncorporatedFeb 2024DIN 02545411Approved
DenosumabWyostSandozSandoz Canada IncorporatedMar 2024DIN 02545764Approved
DenosumabOsenveltCelltrionCelltrion INC.Sep 2025DIN 02560895Approved
DenosumabStobocloCelltrionCelltrion INC.Sep 2025DIN 02560917Approved
DenosumabBildyosShanghai Henlius BiotechShanghai Henlius Biotech, INC.Mar 2026DIN 02565951Approved
DenosumabTuzemtyShanghai Henlius BiotechShanghai Henlius Biotech, INC.Mar 2026DIN 02566001Approved
DenosumabDenozaApotexApotex INCMar 2026DIN 02566265Approved
EculizumabBekemvAmgenAmgen Canada INCApr 2026DIN 02540509Withdrawn
Enoxaparin sodiumNorombyJuno Pharma CanadaJuno Pharma Canada INC.Oct 2020DIN 02506459, 02506467, 02506475, 02506483, 02506491, 02506505, 02506513Approved
Enoxaparin sodiumInclunoxSandozSandoz Canada IncorporatedNov 2020DIN 02507501, 02507528, 02507536, 02507544, 02507552, 02507560, 02507579Approved
Enoxaparin sodiumRedescaTechdowShenzhen Techdow Pharmaceutical CO., LTD.Dec 2020DIN 02509075, 02509083, 02509091, 02509105, 02509113, 02509121, 02509148, 02509156Approved
Enoxaparin sodiumElonoxFresenius KabiFresenius Kabi Canada LTDOct 2022DIN 02532247, 02532255, 02532263, 02532271, 02532298, 02532301, 02532328Approved
Enoxaparin sodiumAxberiBaxterBaxter CorporationJul 2023DIN 02539977, 02539985, 02540002, 02540010, 02540045, 02540029, 02540037Approved
EtanerceptBrenzysSamsung BioepisSamsung Bioepis CO., LTDAug 2016DIN 02455323, 02455331Approved
EtanerceptErelziSandozSandoz Canada IncorporatedApr 2017DIN 02462850, 02462869, 02462877Approved
EtanerceptRymtiLupinLupin Pharma Canada LimitedAug 2022DIN 02530295, 02530309Approved
FilgrastimGrastofilIntas PharmaceuticalsApotex INCDec 2015DIN 02441489, 02454548Approved
FilgrastimNivestymPfizerPfizer Canada ULCApr 2020DIN 02485575, 02485583, 02485591, 02485656Approved
FilgrastimNypoziTanvex BioPharmaTanvex Biopharma Usa, INC.Oct 2021DIN 02520990, 02521008Approved
InfliximabRemdantryCelltrionCelltrion INC.Jan 2014DIN 02419475Approved
InfliximabRemsimaCelltrionCelltrion INC.Jan 2014DIN 02419483Withdrawn
InfliximabRenflexisSamsung BioepisSamsung Bioepis CO., LTDDec 2017DIN 02470373Approved
InfliximabAvsolaAmgenAmgen Canada INCMar 2020DIN 02496933Approved
InfliximabRemsima SCCelltrionCelltrion INC.Jan 2021DIN 02511584Approved
InfliximabIxifiPfizerPfizer Canada ULCDec 2021DIN 02523191Approved
Insulin aspartTrurapiSanofiSanofi-aventis Canada INCOct 2020DIN 02506564, 02506572, 02529254Approved
Insulin aspartKirstyBiocon BiologicsBiocon Biologics Canada INCOct 2021DIN 02520974Approved
Insulin glargineBasaglarEli LillyEli Lilly Canada INCSep 2015DIN 02444844, 02444852, 02461528Approved
Insulin glargineSemgleeBiocon BiologicsBiocon SDN.BHDApr 2022DIN 02526441Approved
Insulin humanMyxredlinBaxterBaxter CorporationAug 2022DIN 02529602Approved
Insulin lisproAdmelogSanofiSanofi-aventis Canada INCNov 2017DIN 02469898, 02469901, 02469871Approved
OmalizumabOmlycloCelltrionCelltrion INC.Dec 2024DIN 02553805, 02553813, 02561018, 02561026Approved
PegfilgrastimLapelgaIntas PharmaceuticalsApotex INCApr 2018DIN 02474565, 02529343Approved
PegfilgrastimFulphilaBiocon BiologicsBiocon Biologics Canada INCDec 2018DIN 02484153Approved
PegfilgrastimZiextenzoSandozSandoz Canada IncorporatedApr 2020DIN 02497395Approved
PegfilgrastimNyvepriaPfizerPfizer Canada ULCOct 2020DIN 02506238Approved
PegfilgrastimNiopegNora PharmaNora Pharma INCApr 2024DIN 02546973Approved
RanibizumabMelvizoSamsung BioepisSamsung Bioepis CO., LTDMar 2022DIN 02525852Approved
RanibizumabRanoptoTevaTeva Canada LimitedOct 2023DIN 02542250Approved
RituximabTruximaCelltrionCelltrion INC.Apr 2019DIN 02478382, 02478390Approved
RituximabRiximyoSandozSandoz Canada IncorporatedApr 2020DIN 02498316Approved
RituximabRuxiencePfizerPfizer Canada ULCMay 2020DIN 02495724Approved
RituximabRiabniAmgenAmgen Canada INCMar 2021DIN 02513447Withdrawn
SomatropinOmnitropeSandozSandoz Canada IncorporatedApr 2009DIN 02325055, 02325063, 02325071, 02459647Approved
TeriparatideOsnuvoAvir PharmaAvir Pharma INC.Jan 2020DIN 02495589Approved
TocilizumabTyenneFresenius KabiFresenius Kabi Canada LTDOct 2024DIN 02552450, 02552469, 02552477, 02552485, 02552493Approved
TocilizumabAvtozmaCelltrionCelltrion INC.Oct 2025DIN 02562022, 02562030, 02562049, 02562057, 02562065Approved
TrastuzumabOgivriBiocon BiologicsBiosimilar Collaborations Ireland LimitedMay 2019DIN 02474425, 02474433Approved
TrastuzumabTrazimeraPfizerPfizer Canada ULCAug 2019DIN 02483467, 02483475Approved
TrastuzumabHerzumaCelltrionCelltrion INC.Sep 2019DIN 02480794, 02506211Approved
TrastuzumabKanjintiAmgenAmgen Canada INCFeb 2020DIN 02496690, 02518244Approved
TrastuzumabOntruzantSamsung BioepisSamsung Bioepis CO., LTDJan 2022DIN 02524317, 02524325Approved
UstekinumabJamtekiAlvotechJamp Pharma CorporationNov 2023DIN 02543036, 02543044Approved
UstekinumabSteqeymaCelltrionCelltrion INC.Jul 2024DIN 02550245, 02550253, 02550261Approved
UstekinumabPyzchivaSamsung BioepisSamsung Bioepis CO., LTDAug 2024DIN 02550539, 02550547, 02550520Approved
UstekinumabWezlanaAmgenAmgen Canada INCNov 2024DIN 02553309, 02553317Approved
UstekinumabOtulfiFormyconFresenius Kabi Canada LTDDec 2024DIN 02554283, 02554291, 02554305Approved
UstekinumabYesintekBiocon BiologicsBiocon Biologics Canada INCOct 2025DIN 02562081, 02562103, 02562111Approved

Records checked against HC's files, Sep 2026.

How HC assesses a biosimilar

Legal pathwayNotice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026)
Reference productReference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data
Comparative clinical studyComparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA
InterchangeabilityNo federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019
NamingNon-proprietary name identical to the reference, with brand name and DIN as identifiers

Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs.

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Sources

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Data current to September 2026.