Generics and Biosimilars Initiatives (GaBI）onlineが2024年7月までに欧州で承認されたバイオシミラーをまとめている。
欧州連合（EU）では、バイオシミラー承認に関する法的枠組みが2003年に確立し、イノベーティブバイオ医薬品と同様、バイオシミラーについてもEMAを通じて一元的に承認される。EMAが最初に承認したバイオシミラーはソマトロピン（オムニトロープ）であり、2024年7月までに106のバイオシミラーの承認を推奨しているとのことである（表1は承認済みのバイオシミラー）。
一方で、17件のバイオシミラーが承認後に取り下げられており、表2には、EMAが拒否あるいは承認撤回したバイオシミラーを示している。
表1 EMA承認バイオシミラー（2024年7月16日更新）
| Active substance | Product name | Manufacturer/Company name | Authorization date | ||
| 1 | adalimumab | 1 | Amgevita | Amgen | 21-Mar-17 |
| 2 | Amsparity | Pfizer | 13-Feb-20 | ||
| 3 | Hefiya | Sandoz | 26-Jul-18 | ||
| 4 | Hukyndra | Alvotech/Stada Artnimettel | 15-Nov-21 | ||
| 5 | Hulio | Mylan/Fujifilm Kyowa Kirin Biologics | 17-Sep-18 | ||
| 6 | Hyrimoz | Sandoz | 26-Jul-18 | ||
| 7 | Idacio | Fresenius Kabi | 2-Apr-19 | ||
| 8 | Imraldi | Samsung Bioepis | 24-Aug-17 | ||
| 9 | Libmyris | Alvotech/Stada Artnimettel | 12-Nov-21 | ||
| 10 | Yuflyma | Celltrion Healthcare | 11-Feb-21 | ||
| 2 | aflibercept | 11 | Yesafili | Biocon/Viatris (formerly Mylan) | 15-Sep-23 |
| 3 | bevacizumab | 12 | Abevmy | Mylan (now Viatris) | 21-Apr-21 |
| 13 | Alymsys | mAbxience Research | 26-Mar-21 | ||
| 14 | Aybintio | Samsung Bioepis | 19-Aug-20 | ||
| 15 | Avzivi | Bio-Thera Solutions | CHMP positive opinion 30 May 2024 | ||
| 16 | Mvasi | Amgen | 15-Jan-18 | ||
| 17 | Onbevzi | Samsung Bioepis | 11-Jan-21 | ||
| 18 | Oyavas | Stada Arzneimittel | 26-Mar-21 | ||
| 19 | Vegzelma | Celltrion Healthcare | 17-Aug-22 | ||
| 20 | Zirabev | Pfizer | 14-Feb-19 | ||
| 4 | denosumab | 21 | Jubbonti | Sandoz GmbH | 16-May-24 |
| 22 | Wyost | Sandoz GmbH | 16-May-24 | ||
| 5 | eculizumab | 23 | Bekemv | Amgen | 24-Feb-23 |
| 24 | Epysqli | Samsung Bioepis | 26-May-23 ,22-Mar-24 (for aHUS) | ||
| 6 | Enoxaparin sodium | 25 | Enoxaparin BECAT | Laboratorios ROVI | 24-Mar-17 |
| 26 | Inhixa | Techdow Europe | 15-Sep-16 | ||
| 7 | epoetin alfa | 27 | Abseamed | Medice Arzneimittel Pütter | 27-Aug-07 |
| 28 | Binocrit | Sandoz | 28-Aug-07 | ||
| 29 | Epoetin alfa Hexal | Hexal | 27-Aug-07 | ||
| 8 | epoetin zeta | 30 | Retacrit | Hospira (Pfizer) | 18-Dec-07 |
| 31 | Silapo | Stada Arzneimittel | 18-Dec-07 | ||
| 9 | etanercept | 32 | Benepali | Samsung Bioepis | 13-Jan-16 |
| 33 | Erelzi | Sandoz | 23-Jun-17 | ||
| 34 | Nepexto | Mylan | 25-May-20 | ||
| 10 | filgrastim | 35 | Accofil | Accord Healthcare | 17-Sep-14 |
| 36 | Filgrastim Hexal | Hexal | 6-Feb-09 | ||
| 37 | Grastofil | Apotex | 17-Oct-13 | ||
| 38 | Nivestim | Hospira (Pfizer) | 7-Jun-10 | ||
| 39 | Ratiograstim | Ratiopharm | 15-Sep-08 | ||
| 40 | Tevagrastim | Teva Generics | 15-Sep-08 | ||
| 41 | Zarzio | Sandoz | 6-Feb-09 | ||
| 11 | follitropin alfa | 42 | Bemfola | Finox Biotech | 26-Mar-14 |
| 43 | Ovaleap | Teva Pharma | 27-Sep-13 | ||
| 12 | infliximab | 44 | Flixabi | Samsung Bioepis | 26-May-16 |
| 45 | Inflectra | Hospira (Pfizer) | 10-Sep-13 | ||
| 46 | Remsima | Celltrion | 10-Sep-13 | ||
| 47 | Zessly | Sandoz | 18-May-18 | ||
| 13 | insulin aspart | 48 | Insulin aspart Sanofi | Sanofi-Aventis | 25-Jun-20 |
| 49 | Kirsty (previously Kixelle) | Biocon/Viatris (formerly Mylan) | 5-Feb-21 | ||
| 50 | Truvelog Mix 30 | Sanofi-Aventis | Apr-22 | ||
| 14 | insulin glargine | 51 | Abasaglar (previously Abasria) | Eli Lilly/Boehringer Ingelheim | 9-Sep-14 |
| 52 | Semglee | Biocon/Viatris (formerly Mylan) | 28-Mar-18 | ||
| 15 | insulin lispro | 53 | Insulin lispro Sanofi | Sanofi-Aventis | 18-Jul-17 |
| 16 | natalizumab | 54 | Tyruko | Sandoz GmbH | 26-Sep-23 |
| 17 | omalizumab | 55 | Omlyclo | Celltrion Healthcare | 23-May-24 |
| 18 | pegfilgrastim | 56 | Cegfila (previously Pegfilgrastim Mundipharma) | Mundipharma Biologics | 19-Dec-19 |
| 57 | Fulphila | Mylan | 20-Nov-18 | ||
| 58 | Grasustek | Juta Pharma (USV) | 20-Jun-19 | ||
| 59 | Nyvepria | Pfizer | 18-Nov-20 | ||
| 60 | Pelgraz | Accord Healthcare | 21-Sep-18 | ||
| 61 | Pelmeg | Cinfa Biotech/Mundipharma | 20-Nov-18 | ||
| 62 | Stimufend | Fresenius Kabi | 24-Mar-22 | ||
| 63 | Ziextenzo | Sandoz | 22-Nov-18 | ||
| 19 | ranibizumab | 64 | Byooviz | Samsung Bioepis | 18-Aug-21 |
| 65 | Ranivisio | Bioeq/Teva Pharma | 25-Aug-22 | ||
| 66 | Rimmyrah | Qilu Pharma | 5-Jan-24 | ||
| 67 | Ximluci | Stada Arzneimittel/Xbrane Biopharma | 9-Nov-22 | ||
| 20 | rituximab | 68 | Blitzima | Celltrion | 13-Jul-17 |
| 69 | Rixathon | Sandoz | 15-Jun-17 | ||
| 70 | Riximyo | Sandoz | 15-Jun-17 | ||
| 71 | Ruxience | Pfizer | 1-Apr-20 | ||
| 72 | Truxima | Celltrion Healthcare | 17-Feb-17 | ||
| 21 | somatropin | 73 | Omnitrope | Sandoz | 12-Apr-06 |
| 22 | teriparatide | 74 | Livogiva | Theramex Ireland | 27-Aug-20 |
| 75 | Movymia | Stada Arzneimittel | 11-Jan-17 | ||
| 76 | Sondelbay | Accord Healthcare | 24-Mar-22 | ||
| 77 | Terrosa | Gedeon Richter | 4-Jan-17 | ||
| 23 | tocilizumab | 78 | Tofidence | Biogen | CHMP positive opinion 25 Apr 2024 |
| 79 | Tyenne | Fresenius Kabi Deutschland GmbH | 15-Sep-23 | ||
| 24 | trastuzumab | 80 | Herzuma | Celltrion Healthcare | 8-Feb-18 |
| 81 | Herwenda | Sandoz GmbH | 15-Nov-23 | ||
| 82 | Kanjinti | Amgen/Allergan | 16-May-18 | ||
| 83 | Ogivri | Biocon/Mylan | 12-Dec-18 | ||
| 84 | Ontruzant | Samsung Bioepis | 15-Nov-17 | ||
| 85 | Trazimera | Pfizer | 26-Jul-18 | ||
| 86 | Zercepac | Accord Healthcare | 27-Jul-20 | ||
| 25 | ustekinumab | 87 | Pyzchiva | Samsung Bioepis | 22-Apr-24 |
| 88 | Uzpruvo | Alvotech/Stada Arzneimittel AG | 5-Jan-24 | ||
| 89 | Wezenla | Amgen | CHMP positive opinion 25 Apr 2024 |
Generics and Biosimilars Initiatives： Biosimilars approved in Europe.( Last update: 16 July 2024)をもとに著者改変
表2 EMAが拒否／撤回したバイオシミラー（2024年7月16日更新）
| Active substance | Product name | Manufacturer/Company name | Authorization date |
| interferon alfa- 2a | Alpheon | BioPartners | Refused 5 Sep 2006 |
| filgrastim | Biograstim | CT Arzneimittel | 15 Sep 2008 Withdrawn on 22 Dec 2016 |
| pegfilgrastim | Cavoley | Stada Artnimettel | Withdrawn on 20 Dec 2018 |
| adalimumab | Cyltezo | Boehringer Ingelheim | 10 Nov 2017 Withdrawn on 15 Jan 2019 |
| pegfilgrastim | Efgratin | Gedeon Richter | Withdrawn on 16 Nov 2016 |
| epoetin alfa | Epostim | Reliance GeneMedix | Withdrawn 15 Mar 2011 |
| bevacizumab | Equidacent | Centus Biotherapeutics | 24 Sep 2020 Withdrawn on 23 Nov 2021 |
| filgrastim | Filgrastim ratiopharm | Ratiopharm | 15 Sep 2008 Withdrawn on 20 Apr 2011 |
| adalimumab | Halimatoz | Sandoz | 26 Jul 2018 Withdrawn on 29 Jan 2021 |
| insulin human | Inpremzia | 25 Apr 2022 Withdrawn on 20 Apr 2023 | |
| adalimumab | Kromeya | Fresenius Kabi | 2 Apr 2019 Withdrawn on 17 Dec 2019 |
| bevacizumab | Lextemy | Mylan (now Viatris) | CHMP positive opinion 25 Feb 2021 Withdrawn on 14 Dec 2021 |
| insulin glargine | Lusduna | Merck (MSD) | 3 Jan 2017 Withdrawn on 29 Oct 2018 |
| teriparatide | Qutavina | EuroGenerics Holdings | 27 Aug 2020 Withdrawn on 18 Jan 2021 |
| rituximab | Ritemvia | Celltrion | 13 Jul 2017 Withdrawn on 16 Aug 2021 |
| rituximab | Rituximab Mabion | Mabion | Withdrawn on 16 Mar 2020 |
| rituximab | Rituzena (previously Tuxella) | Celltrion | 13 Jul 2017 Withdrawn on 10 Apr 2019 |
| insulin human | Solumarv | Marvel Lifesciences | Refused 11 Feb 2016 |
| adalimumab | Solymbic | Amgen | 22 Mar 2017 Withdrawn on 5 Mar 2019 |
| somatropin | Somatropin Biopartners | BioPartners | 9 Sep 2013 Withdrawn on 9 Nov 2017 |
| enoxaparin sodium | Thorinane | Pharmathen | 14 Sep 2016 Withdrawn on 24 Oct 2019 |
| pegfilgrastim | Udenyca | ERA Consulting (Coherus Biosciences) | 21 Sep 2018 Withdrawn on 15 Feb 2021 |
| somatropin | Valtropin | BioPartners | 24 Apr 2006 Withdrawn on 10 May 2012 |
Generics and Biosimilars Initiatives： Biosimilars approved in Europe.( Last update: 16 July 2024)をもとに著者改変
ニュースソース
Generics and Biosimilars Initiatives： Biosimilars approved in Europe.( Last update: 16 July 2024)
https://gabionline.net/biosimilars/general/biosimilars-approved-in-europe?sender_campaign=b8Noqm&sender_ctype=email&sender_customer=j%E2%80%A6
キーワード
＃バイオシミラー
＃EMA
2024年7月17日