Biosimilars in European Union
Biosimilars authorised by the European Commission on CHMP opinion, with product numbers, holders, withdrawals and the applications currently under evaluation.
Regulator: European Medicines Agency and European Commission
EMAproducts approved110
EMAmolecules with a biosimilar26
EMAwithdrawn28
EMAunder review17
By molecule
Products approved per molecule.
Denosumab29Aflibercept12Ustekinumab11Adalimumab10Pegfilgrastim10Bevacizumab8Ranibizumab8Trastuzumab8Filgrastim7Rituximab6Teriparatide6Epoetin alfa and zeta5Etanercept4Tocilizumab4Infliximab3Insulin aspart3Insulin glargine3Eculizumab2Follitropin alfa2Golimumab2Insulin lispro2Enoxaparin sodium1Natalizumab1Omalizumab1Pertuzumab1Somatropin1
Every record
| Molecule | Brand | Developer | Holder or applicant | Approved | Application or permission | Status |
|---|---|---|---|---|---|---|
| Abatacept | Application 006741 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Jun 2026 | EMEA/H/C/006741 | Under review |
| Adalimumab | Amgevita | Amgen | Amgen Europe B.V. | Mar 2017 | EMEA/H/C/004212 | Approved |
| Adalimumab | Solymbic | Amgen | Amgen Europe B.V. | Mar 2017 | EMEA/H/C/004373 | Withdrawn |
| Adalimumab | Imraldi | Samsung Bioepis | Samsung Bioepis NL B.V. | Aug 2017 | EMEA/H/C/004279 | Approved |
| Adalimumab | Cyltezo | Boehringer Ingelheim | Boehringer Ingelheim International GmbH | Nov 2017 | EMEA/H/C/004319 | Withdrawn |
| Adalimumab | Hyrimoz | Sandoz | Sandoz GmbH | Jul 2018 | EMEA/H/C/004320 | Approved |
| Adalimumab | Hefiya | Sandoz | Sandoz GmbH | Jul 2018 | EMEA/H/C/004865 | Approved |
| Adalimumab | Halimatoz | Sandoz | Sandoz GmbH | Jul 2018 | EMEA/H/C/004866 | Withdrawn |
| Adalimumab | Hulio | Fujifilm Kyowa Kirin Biologics | Biosimilar Collaborations Ireland Limited | Sep 2018 | EMEA/H/C/004429 | Approved |
| Adalimumab | Idacio | Fresenius Kabi | Fresenius Kabi Deutschland GmbH | Apr 2019 | EMEA/H/C/004475 | Approved |
| Adalimumab | Kromeya | Fresenius Kabi | Fresenius Kabi Deutschland GmbH | Apr 2019 | EMEA/H/C/005158 | Withdrawn |
| Adalimumab | Amsparity | Pfizer | Pfizer Europe MA EEIG | Feb 2020 | EMEA/H/C/004879 | Approved |
| Adalimumab | Yuflyma | Celltrion | Celltrion Healthcare Hungary Kft. | Feb 2021 | EMEA/H/C/005188 | Approved |
| Adalimumab | Libmyris | Alvotech | Stada Arzneimittel AG | Nov 2021 | EMEA/H/C/005947 | Approved |
| Adalimumab | Hukyndra | Alvotech | Stada Arzneimittel AG | Nov 2021 | EMEA/H/C/005548 | Approved |
| Aflibercept | Yesafili | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Sep 2023 | EMEA/H/C/006022 | Approved |
| Aflibercept | Opuviz | Samsung Bioepis | Samsung Bioepis NL B.V. | Nov 2024 | EMEA/H/C/006056 | Approved |
| Aflibercept | Afqlir | Sandoz | Sandoz GmbH | Nov 2024 | EMEA/H/C/006150 | Approved |
| Aflibercept | Ahzantive | Formycon | Formycon AG | Jan 2025 | EMEA/H/C/006607 | Approved |
| Aflibercept | Baiama | Formycon | Formycon AG | Jan 2025 | EMEA/H/C/005980 | Approved |
| Aflibercept | Eydenzelt | Celltrion | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/005899 | Approved |
| Aflibercept | Pavblu | Amgen | Amgen Technology (Ireland) UC | Apr 2025 | EMEA/H/C/006339 | Approved |
| Aflibercept | Eiyzey | Sam Chun Dang Pharm | Zaklady Farmaceutyczne Polpharma S.A. | Aug 2025 | EMEA/H/C/006745 | Approved |
| Aflibercept | Vgenfli | Sam Chun Dang Pharm | Zaklady Farmaceutyczne Polpharma S.A. | Aug 2025 | EMEA/H/C/006192 | Approved |
| Aflibercept | Afiveg | Alvotech | STADA Arzneimittel AG | Aug 2025 | EMEA/H/C/006761 | Approved |
| Aflibercept | Mynzepli | Alvotech | Advanz Pharma Limited | Aug 2025 | EMEA/H/C/006438 | Approved |
| Aflibercept | Eyluxvi | Alteogen | Biolitec pharma Limited Zweigniederlassung Jena | Sep 2025 | EMEA/H/C/006282 | Approved |
| Aflibercept | Skojoy | Amgen | Amgen Technology (Ireland) UC | not published | EMEA/H/C/006551 | Withdrawn |
| Bevacizumab | Mvasi | Amgen | Amgen Technology (Ireland) UC | Jan 2018 | EMEA/H/C/004728 | Approved |
| Bevacizumab | Zirabev | Pfizer | Pfizer Europe MA EEIG | Feb 2019 | EMEA/H/C/004697 | Approved |
| Bevacizumab | Aybintio | Samsung Bioepis | Samsung Bioepis NL B.V. | Aug 2020 | EMEA/H/C/005106 | Approved |
| Bevacizumab | Equidacent | Centus Biotherapeutics | Centus Biotherapeutics Europe Limited | Sep 2020 | EMEA/H/C/005181 | Withdrawn |
| Bevacizumab | Onbevzi | Samsung Bioepis | Samsung Bioepis NL B.V. | Jan 2021 | EMEA/H/C/005640 | Withdrawn |
| Bevacizumab | Alymsys | mAbxience | Mabxience Research SL | Mar 2021 | EMEA/H/C/005286 | Approved |
| Bevacizumab | Oyavas | mAbxience | STADA Arzneimittel AG | Mar 2021 | EMEA/H/C/005556 | Approved |
| Bevacizumab | Abevmy | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Apr 2021 | EMEA/H/C/005327 | Approved |
| Bevacizumab | Vegzelma | Celltrion | Celltrion Healthcare Hungary Kft. | Aug 2022 | EMEA/H/C/005534 | Approved |
| Bevacizumab | Avzivi | Bio-Thera Solutions | FGK Representative Service GmbH | Jul 2024 | EMEA/H/C/005574 | Approved |
| Bevacizumab | Lextemy | Viatris | Mylan IRE Healthcare Limited | not published | EMEA/H/C/005611 | Withdrawn |
| Bevacizumab | Application 005995 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Dec 2025 | EMEA/H/C/005995 | Under review |
| Bevacizumab | Application 006944 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006944 | Under review |
| Denosumab | Jubbonti | Sandoz | Sandoz GmbH | May 2024 | EMEA/H/C/005964 | Approved |
| Denosumab | Wyost | Sandoz | Sandoz GmbH | May 2024 | EMEA/H/C/006378 | Approved |
| Denosumab | Obodence | Samsung Bioepis | Samsung Bioepis NL B.V. | Feb 2025 | EMEA/H/C/006424 | Approved |
| Denosumab | Xbryk | Samsung Bioepis | Samsung Bioepis NL B.V. | Feb 2025 | EMEA/H/C/006468 | Approved |
| Denosumab | Stoboclo | Celltrion | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/006156 | Approved |
| Denosumab | Osenvelt | Celltrion | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/006157 | Approved |
| Denosumab | Osvyrti | Intas Pharmaceuticals | Accord Healthcare S.L.U. | May 2025 | EMEA/H/C/006399 | Approved |
| Denosumab | Jubereq | Intas Pharmaceuticals | Accord Healthcare S.L.U. | May 2025 | EMEA/H/C/006398 | Approved |
| Denosumab | Junod | Gedeon Richter | Gedeon Richter Plc. | Jun 2025 | EMEA/H/C/006436 | Approved |
| Denosumab | Yaxwer | Gedeon Richter | Gedeon Richter Plc. | Jun 2025 | EMEA/H/C/006437 | Approved |
| Denosumab | Vevzuo | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Jun 2025 | EMEA/H/C/006534 | Approved |
| Denosumab | Denbrayce | mAbxience | Mabxience Research SL | Jun 2025 | EMEA/H/C/006199 | Approved |
| Denosumab | Izamby | mAbxience | Mabxience Research SL | Jun 2025 | EMEA/H/C/006152 | Approved |
| Denosumab | Zadenvi | mAbxience | Zentiva k.s. | Jun 2025 | EMEA/H/C/006377 | Approved |
| Denosumab | Enwylma | mAbxience | Zentiva k.s. | Jun 2025 | EMEA/H/C/006376 | Approved |
| Denosumab | Evfraxy | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Jun 2025 | EMEA/H/C/006526 | Approved |
| Denosumab | Bomyntra | Fresenius Kabi | Fresenius Kabi Deutschland GmbH | Jul 2025 | EMEA/H/C/006269 | Approved |
| Denosumab | Rolcya | Sandoz | Sandoz GmbH | Jul 2025 | EMEA/H/C/006507 | Approved |
| Denosumab | Conexxence | Fresenius Kabi | Fresenius Kabi Deutschland GmbH | Jul 2025 | EMEA/H/C/006268 | Approved |
| Denosumab | Bilprevda | Shanghai Henlius Biotech | Sciencepharma Sp. z o.o | Sep 2025 | EMEA/H/C/006435 | Approved |
| Denosumab | Bildyos | Shanghai Henlius Biotech | Sciencepharma Sp. z o.o | Sep 2025 | EMEA/H/C/006434 | Approved |
| Denosumab | Vysribli | Intas Pharmaceuticals | Intas Third Party Sales 2005 S.L. | Nov 2025 | EMEA/H/C/006797 | Approved |
| Denosumab | Zvogra | Alvotech | Stada Arzneimittel AG | Nov 2025 | EMEA/H/C/006552 | Approved |
| Denosumab | Kefdensis | Alvotech | Stada Arzneimittel AG | Nov 2025 | EMEA/H/C/006490 | Approved |
| Denosumab | Xbonzy | Alvotech | Reddy Holding GmbH | Nov 2025 | EMEA/H/C/006722 | Approved |
| Denosumab | Acvybra | Alvotech | Reddy Holding GmbH | Nov 2025 | EMEA/H/C/006734 | Approved |
| Denosumab | Degevma | Teva | Teva GmbH | Nov 2025 | EMEA/H/C/006239 | Approved |
| Denosumab | Ponlimsi | Teva | Teva GmbH | Nov 2025 | EMEA/H/C/006238 | Approved |
| Denosumab | Osqay | Enzene Biosciences | Theramex Ireland Limited | Jan 2026 | EMEA/H/C/006492 | Approved |
| Denosumab | Denosumab Ascend | Ascend | Ascend GmbH | opinion Jun 2026 | EMEA/H/C/006626 | Under review |
| Denosumab | Application 006710 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006710 | Under review |
| Denosumab | Application 006719 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006719 | Under review |
| Eculizumab | Bekemv | Amgen | Amgen Technology (Ireland) UC | Apr 2023 | EMEA/H/C/005652 | Approved |
| Eculizumab | Epysqli | Samsung Bioepis | Samsung Bioepis NL B.V. | May 2023 | EMEA/H/C/006036 | Approved |
| Enoxaparin sodium | Thorinane | Pharmathen | Pharmathen S.A. | Sep 2016 | EMEA/H/C/003795 | Withdrawn |
| Enoxaparin sodium | Inhixa | Techdow | Techdow Pharma Netherlands B.V. | Sep 2016 | EMEA/H/C/004264 | Approved |
| Epoetin alfa and zeta | Epoetin alfa Hexal | Sandoz | Hexal AG | Aug 2007 | EMEA/H/C/000726 | Approved |
| Epoetin alfa and zeta | Abseamed | Sandoz | Medice Arzneimittel Pütter GmbH Co. KG | Aug 2007 | EMEA/H/C/000727 | Approved |
| Epoetin alfa and zeta | Binocrit | Sandoz | Sandoz GmbH | Aug 2007 | EMEA/H/C/000725 | Approved |
| Epoetin alfa and zeta | Silapo | Norbitec | Stada Arzneimittel AG | Dec 2007 | EMEA/H/C/000760 | Approved |
| Epoetin alfa and zeta | Retacrit | Norbitec | Pfizer Europe MA EEIG | Dec 2007 | EMEA/H/C/000872 | Approved |
| Etanercept | Benepali | Samsung Bioepis | Samsung Bioepis NL B.V. | Jan 2016 | EMEA/H/C/004007 | Approved |
| Etanercept | Erelzi | Sandoz | Sandoz GmbH | Jun 2017 | EMEA/H/C/004192 | Approved |
| Etanercept | Nepexto | Lupin | Biosimilar Collaborations Ireland Limited | May 2020 | EMEA/H/C/004711 | Approved |
| Etanercept | Fubelv | Lupin | Biosimilar Collaborations Ireland Limited | Apr 2026 | EMEA/H/C/006738 | Approved |
| Filgrastim | Tevagrastim | Teva | Teva GmbH | Sep 2008 | EMEA/H/C/000827 | Approved |
| Filgrastim | Ratiograstim | Teva | Ratiopharm GmbH | Sep 2008 | EMEA/H/C/000825 | Approved |
| Filgrastim | Biograstim | Teva | AbZ-Pharma GmbH | Sep 2008 | EMEA/H/C/000826 | Withdrawn |
| Filgrastim | Filgrastim ratiopharm | Teva | Ratiopharm GmbH | Sep 2008 | EMEA/H/C/000824 | Withdrawn |
| Filgrastim | Zarzio | Sandoz | Sandoz GmbH | Feb 2009 | EMEA/H/C/000917 | Approved |
| Filgrastim | Filgrastim Hexal | Sandoz | Hexal AG | Feb 2009 | EMEA/H/C/000918 | Approved |
| Filgrastim | Nivestim | Pfizer | Pfizer Europe MA EEIG | Jun 2010 | EMEA/H/C/001142 | Approved |
| Filgrastim | Grastofil | Intas Pharmaceuticals | Accord Healthcare S.L.U. | Oct 2013 | EMEA/H/C/002150 | Withdrawn |
| Filgrastim | Accofil | Intas Pharmaceuticals | Accord Healthcare S.L.U. | Sep 2014 | EMEA/H/C/003956 | Approved |
| Filgrastim | Zefylti | CuraTeQ Biologics | CuraTeQ Biologics (Malta) Limited | Feb 2025 | EMEA/H/C/006400 | Approved |
| Filgrastim | Application 007009 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/007009 | Under review |
| Follitropin alfa | Ovaleap | Teva | Theramex Ireland Limited | Sep 2013 | EMEA/H/C/002608 | Approved |
| Follitropin alfa | Bemfola | Finox Biotech | Gedeon Richter Plc. | Mar 2014 | EMEA/H/C/002615 | Approved |
| Golimumab | Gobivaz | Alvotech | Advanz Pharma Limited | Nov 2025 | EMEA/H/C/006560 | Approved |
| Golimumab | Gotenfia | Alvotech | Stada Arzneimittel AG | Feb 2026 | EMEA/H/C/006621 | Approved |
| Infliximab | Remsima | Celltrion | Celltrion Healthcare Hungary Kft. | Sep 2013 | EMEA/H/C/002576 | Approved |
| Infliximab | Inflectra | Celltrion | Pfizer Europe MA EEIG | Sep 2013 | EMEA/H/C/002778 | Withdrawn |
| Infliximab | Flixabi | Samsung Bioepis | Samsung Bioepis NL B.V. | May 2016 | EMEA/H/C/004020 | Approved |
| Infliximab | Zessly | Pfizer | Sandoz GmbH | May 2018 | EMEA/H/C/004647 | Approved |
| Insulin aspart | Insulin aspart Sanofi | Sanofi | Sanofi Winthrop Industrie | Jun 2020 | EMEA/H/C/005033 | Approved |
| Insulin aspart | Kirsty | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Feb 2021 | EMEA/H/C/004965 | Approved |
| Insulin aspart | Truvelog Mix 30 | Sanofi | Sanofi Winthrop Industrie | Apr 2022 | EMEA/H/C/005635 | Withdrawn |
| Insulin aspart | Dazparda | Gan & Lee Pharmaceuticals | Gan & Lee Pharmaceuticals Europe GmbH | Apr 2026 | EMEA/H/C/006187 | Approved |
| Insulin aspart | Application 006677 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Nov 2025 | EMEA/H/C/006677 | Under review |
| Insulin aspart | Application 006864 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Nov 2025 | EMEA/H/C/006864 | Under review |
| Insulin glargine | Abasaglar | Eli Lilly | Eli Lilly Nederland B.V. | Sep 2014 | EMEA/H/C/002835 | Approved |
| Insulin glargine | Lusduna | Merck Sharp & Dohme | Merck Sharp & Dohme B.V. | Jan 2017 | EMEA/H/C/004101 | Withdrawn |
| Insulin glargine | Semglee | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Mar 2018 | EMEA/H/C/004280 | Approved |
| Insulin glargine | Ondibta | Gan & Lee Pharmaceuticals | Sandoz GmbH | Jan 2026 | EMEA/H/C/006136 | Approved |
| Insulin human | Inpremzia | Baxter | Baxter Holding B.V. | Apr 2022 | EMEA/H/C/005331 | Withdrawn |
| Insulin human | Solumarv | Marvel Lifesciences | Marvel Lifesciences Ltd | not published | EMEA/H/C/003858 | Withdrawn |
| Insulin lispro | Insulin lispro Sanofi | Sanofi | Sanofi Winthrop Industrie | Jul 2017 | EMEA/H/C/004303 | Approved |
| Insulin lispro | Bysumlog | Gan & Lee Pharmaceuticals | Gan & Lee Pharmaceuticals Europe GmbH | May 2026 | EMEA/H/C/006158 | Approved |
| Interferon alfa-2b | Alpheon | BioPartners | BioPartners GmbH | not published | EMEA/H/C/000585 | Withdrawn |
| Natalizumab | Tyruko | Polpharma Biologics | Sandoz GmbH | Sep 2023 | EMEA/H/C/005752 | Approved |
| Omalizumab | Omlyclo | Celltrion | Celltrion Healthcare Hungary Kft. | May 2024 | EMEA/H/C/005958 | Approved |
| Omalizumab | Application 006756 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Oct 2025 | EMEA/H/C/006756 | Under review |
| Omalizumab | Application 006687 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Feb 2026 | EMEA/H/C/006687 | Under review |
| Pegfilgrastim | Pelgraz | Intas Pharmaceuticals | Accord Healthcare S.L.U. | Sep 2018 | EMEA/H/C/003961 | Approved |
| Pegfilgrastim | Udenyca | Coherus BioSciences | ERA Consulting GmbH | Sep 2018 | EMEA/H/C/004413 | Withdrawn |
| Pegfilgrastim | Fulphila | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Nov 2018 | EMEA/H/C/004915 | Approved |
| Pegfilgrastim | Pelmeg | Cinfa Biotech | Mundipharma Corporation (Ireland) Limited | Nov 2018 | EMEA/H/C/004700 | Approved |
| Pegfilgrastim | Ziextenzo | Sandoz | Sandoz GmbH | Nov 2018 | EMEA/H/C/004802 | Approved |
| Pegfilgrastim | Grasustek | Juta Pharma | Juta Pharma GmbH | Jun 2019 | EMEA/H/C/004556 | Approved |
| Pegfilgrastim | Cegfila | Cinfa Biotech | Mundipharma Corporation (Ireland) Limited | Dec 2019 | EMEA/H/C/005312 | Approved |
| Pegfilgrastim | Nyvepria | Pfizer | Pfizer Europe MA EEIG | Nov 2020 | EMEA/H/C/005085 | Approved |
| Pegfilgrastim | Stimufend | Fresenius Kabi | Fresenius Kabi Deutschland GmbH | Mar 2022 | EMEA/H/C/004780 | Approved |
| Pegfilgrastim | Dyrupeg | CuraTeQ Biologics | CuraTeQ Biologics (Malta) Limited | Mar 2025 | EMEA/H/C/006407 | Approved |
| Pegfilgrastim | Vivlipeg | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Aug 2025 | EMEA/H/C/006739 | Approved |
| Pegfilgrastim | Nylaspeg | Qilu Pharmaceutical | Qilu Pharma Spain S.L. | opinion Jun 2026 | EMEA/H/C/006085 | Under review |
| Pegfilgrastim | Cavoley | CuraTeQ Biologics | CuraTeQ Biologics s.r.o | opinion Jul 2026 | EMEA/H/C/006937 | Under review |
| Pertuzumab | Poherdy | Shanghai Henlius Biotech | Organon N.V. | Apr 2026 | EMEA/H/C/006583 | Approved |
| Pertuzumab | Application 006844 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Dec 2025 | EMEA/H/C/006844 | Under review |
| Pertuzumab | Application 006893 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Jun 2026 | EMEA/H/C/006893 | Under review |
| Ranibizumab | Byooviz | Samsung Bioepis | Samsung Bioepis NL B.V. | Aug 2021 | EMEA/H/C/005545 | Approved |
| Ranibizumab | Ranivisio | Bioeq | Midas Pharma GmbH | Aug 2022 | EMEA/H/C/005019 | Approved |
| Ranibizumab | Ximluci | Xbrane Biopharma | STADA Arzneimittel AG | Nov 2022 | EMEA/H/C/005617 | Approved |
| Ranibizumab | Rimmyrah | Qilu Pharmaceutical | Qilu Pharma Spain S.L. | Jan 2024 | EMEA/H/C/006055 | Approved |
| Ranibizumab | Epruvy | Bioeq | Midas Pharma GmbH | Sep 2024 | EMEA/H/C/006528 | Approved |
| Ranibizumab | Ranluspec | Lupin | Lupin Europe GmbH | Feb 2026 | EMEA/H/C/006502 | Approved |
| Ranibizumab | Rexatilux | Intas Pharmaceuticals | Intas Third Party Sales 2005 S.L. | Jun 2026 | EMEA/H/C/006634 | Approved |
| Ranibizumab | Vislyfa | Lupin | Lupin Europe GmbH | Jul 2026 | EMEA/H/C/006926 | Approved |
| Rituximab | Truxima | Celltrion | Celltrion Healthcare Hungary Kft. | Feb 2017 | EMEA/H/C/004112 | Approved |
| Rituximab | Rixathon | Sandoz | Sandoz GmbH | Jun 2017 | EMEA/H/C/003903 | Approved |
| Rituximab | Riximyo | Sandoz | Sandoz GmbH | Jun 2017 | EMEA/H/C/004729 | Approved |
| Rituximab | Blitzima | Celltrion | Celltrion Healthcare Hungary Kft. | Jul 2017 | EMEA/H/C/004723 | Approved |
| Rituximab | Ritemvia | Celltrion | Celltrion Healthcare Hungary Kft. | Jul 2017 | EMEA/H/C/004725 | Withdrawn |
| Rituximab | Rituzena | Celltrion | Celltrion Healthcare Hungary Kft. | Jul 2017 | EMEA/H/C/004724 | Withdrawn |
| Rituximab | Ruxience | Pfizer | Pfizer Europe MA EEIG | Apr 2020 | EMEA/H/C/004696 | Approved |
| Rituximab | Ituxredi | Dr. Reddy's Laboratories | Reddy Holding GmbH | Sep 2024 | EMEA/H/C/006224 | Approved |
| Somatropin | Omnitrope | Sandoz | Sandoz GmbH | Apr 2006 | EMEA/H/C/000607 | Approved |
| Somatropin | Valtropin | BioPartners | BioPartners GmbH | Apr 2006 | EMEA/H/C/000602 | Withdrawn |
| Teriparatide | Terrosa | Gedeon Richter | Gedeon Richter Plc. | Jan 2017 | EMEA/H/C/003916 | Approved |
| Teriparatide | Movymia | Gedeon Richter | STADA Arzneimittel AG | Jan 2017 | EMEA/H/C/004368 | Approved |
| Teriparatide | Livogiva | Not stated in the EMA table | Theramex Ireland Limited | Aug 2020 | EMEA/H/C/005087 | Approved |
| Teriparatide | Qutavina | Not stated in the EMA table | EuroGenerics Holdings B.V. | Aug 2020 | EMEA/H/C/005388 | Withdrawn |
| Teriparatide | Sondelbay | Intas Pharmaceuticals | Accord Healthcare S.L.U. | Mar 2022 | EMEA/H/C/005827 | Approved |
| Teriparatide | Kauliv | Strides Pharma | Strides Pharma (Cyprus) Limited | Jan 2023 | EMEA/H/C/004932 | Approved |
| Teriparatide | Zandoriah | CinnaGen | CinnaGen Co Unipessoal LDA | Apr 2026 | EMEA/H/C/006688 | Approved |
| Tocilizumab | Tyenne | Fresenius Kabi | Fresenius Kabi Deutschland GmbH | Sep 2023 | EMEA/H/C/005781 | Approved |
| Tocilizumab | Tocilizumab STADA | Bio-Thera Solutions | STADA Arzneimittel AG | Jun 2024 | EMEA/H/C/005984 | Approved |
| Tocilizumab | Avtozma | Celltrion | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/006196 | Approved |
| Tocilizumab | Tuyory | Gedeon Richter | Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) | Apr 2026 | EMEA/H/C/006416 | Approved |
| Trastuzumab | Ontruzant | Samsung Bioepis | Samsung Bioepis NL B.V. | Nov 2017 | EMEA/H/C/004323 | Approved |
| Trastuzumab | Herzuma | Celltrion | Celltrion Healthcare Hungary Kft. | Feb 2018 | EMEA/H/C/002575 | Approved |
| Trastuzumab | Kanjinti | Amgen | Amgen Europe B.V. | May 2018 | EMEA/H/C/004361 | Approved |
| Trastuzumab | Trazimera | Pfizer | Pfizer Europe MA EEIG | Jul 2018 | EMEA/H/C/004463 | Approved |
| Trastuzumab | Ogivri | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Dec 2018 | EMEA/H/C/004916 | Approved |
| Trastuzumab | Zercepac | Shanghai Henlius Biotech | Accord Healthcare S.L.U. | Jul 2020 | EMEA/H/C/005209 | Approved |
| Trastuzumab | Herwenda | EirGenix | Sandoz GmbH | Nov 2023 | EMEA/H/C/005769 | Approved |
| Trastuzumab | Dazublys | CuraTeQ Biologics | CuraTeQ Biologics (Malta) Limited | Jun 2025 | EMEA/H/C/006219 | Approved |
| Trastuzumab | Tuznue | Prestige Biopharma | Prestige Biopharma Belgium | not published | EMEA/H/C/005066 | Withdrawn |
| Trastuzumab | Hervelous | Prestige Biopharma | Prestige Biopharma Belgium | not published | EMEA/H/C/005880 | Withdrawn |
| Ustekinumab | Uzpruvo | Alvotech | Stada Arzneimittel AG | Jan 2024 | EMEA/H/C/006101 | Approved |
| Ustekinumab | Pyzchiva | Samsung Bioepis | Samsung Bioepis NL B.V. | Apr 2024 | EMEA/H/C/006183 | Approved |
| Ustekinumab | Wezenla | Amgen | Amgen Technology (Ireland) UC | Jun 2024 | EMEA/H/C/006132 | Approved |
| Ustekinumab | Steqeyma | Celltrion | Celltrion Healthcare Hungary Kft. | Aug 2024 | EMEA/H/C/005918 | Approved |
| Ustekinumab | Eksunbi | Samsung Bioepis | Samsung Bioepis NL B.V. | Sep 2024 | EMEA/H/C/006448 | Withdrawn |
| Ustekinumab | Otulfi | Formycon | Fresenius Kabi Deutschland GmbH | Sep 2024 | EMEA/H/C/006544 | Approved |
| Ustekinumab | Fymskina | Formycon | Formycon AG | Sep 2024 | EMEA/H/C/005805 | Approved |
| Ustekinumab | Imuldosa | Dong-A ST | Accord Healthcare S.L.U. | Dec 2024 | EMEA/H/C/006221 | Approved |
| Ustekinumab | Absimky | Dong-A ST | Accord Healthcare S.L.U. | Dec 2024 | EMEA/H/C/006585 | Withdrawn |
| Ustekinumab | Yesintek | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Feb 2025 | EMEA/H/C/006444 | Approved |
| Ustekinumab | Qoyvolma | Celltrion | Celltrion Healthcare Hungary Kft. | Jun 2025 | EMEA/H/C/006649 | Withdrawn |
| Ustekinumab | Usymro | Gedeon Richter | Gedeon Richter Plc. | Aug 2025 | EMEA/H/C/006467 | Approved |
| Ustekinumab | Usrenty | Biocon Biologics | Biosimilar Collaborations Ireland Limited | Sep 2025 | EMEA/H/C/006794 | Approved |
| Ustekinumab | Usgena | Alvotech | Stada Arzneimittel AG | Nov 2025 | EMEA/H/C/006667 | Approved |
| Vedolizumab | Application 006853 | Applicant not yet named by EMA | Applicant not yet named by EMA | since May 2026 | EMEA/H/C/006853 | Under review |
| Vedolizumab | Application 006922 | Applicant not yet named by EMA | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006922 | Under review |
Records checked against EMA's files, Sep 2026.
How EMA assesses a biosimilar
| Legal pathway | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products |
|---|---|
| Reference product | EU-authorised reference; a non-EEA comparator may be used with bridging data |
| Comparative clinical study | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient |
| Interchangeability | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state |
| Naming | INN, identical to the reference; brand name and batch recorded for pharmacovigilance |
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.
EvySaif prepares EMA submissions and regional dossier strategy for biosimilar developers. Regulatory strategy consulting
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 Primary (regulator)
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