Generics and Biosimilars Initiatives (GaBI）onlineは、2026年1月27日記事で、FDAが2025年12月末までに承認したバイオシミラーをまとめている。
FDAは90のバイオシミラーを以下の製品分類において承認している：1) インスリン；2) 顆粒球コロニー刺激因子；3) モノクローナル抗体；4) 腫瘍壊死因子アルファ（TNF-α）；5) 血管内皮増殖因子（VEGF）阻害剤。このうち、25製品 は相互交換可能なバイオシミラーとして承認されている。
また、2025年だけで、FDAは18のバイオシミラーを承認した。これにはアフラセプト（1）、ベバシズマブ（1）、デノスマブ（8）、インスリンアスパルト（2）、オマリズマブ（1）、 ペグフィルグラスチム（1）、ペルツズマブ（1）、ラニビズマブ（1）、トシリズマブ（1）、およびウステキヌマブ（1）が含まれるとされる。
（関連記事）
- 米国で承認されたバイオシミラー（2025年05月23日）
- 米国で承認されたバイオシミラー（2024年07月24日）
- 欧州で承認されたバイオシミラー（2024年07月17日）
- オーストラリアで承認されたバイオシミラー：日本のバイオシミラー・ロスが浮き彫りに（2025年5月7日）
ニュースソース
Generics and Biosimilars Initiatives: Biosimilars approved in the US.
https://gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
FDAが承認したバイオシミラーおよび後続生物学的製剤（follow-on biologicals）
| Active substance | Product name | Authorization date | Manufacturer/ Company |
| adalimumab | Amjevita (adalimumab-atto) | 23-Sep-16 | Amgen |
| Yusimry (adalimumab-aqvh) | 17-Dec-21 | Coherus Biosciences/27 June 2024 acquied by Hong Kong King-Friend Industrial | |
| Idacio (adalimumab-aacf) | 13-Dec-22 | Fresenius Kabi | |
| Yuflyma (adalimumab-aaty) | May-23 | Celltrion | |
| Abrilada (adalimumab-afzb) | 15 Nov 2019 5 Oct 2023§ | Pfizer | |
| Simlandi (adalimumab-ryvk) | 23 Feb 2024§ | Alvotech, marketed by Teva | |
| Hadlima (adalimumab-bwwd) | 23 Jul 2019 27 May 2025§ | Samsung Bioepis | |
| Cyltezo (adalimumab-adbm) | 25 Aug 2017 15 Oct 2021§ | Boehringer Ingelheim | |
| Hyrimoz (adalimumab-adaz) | 30 Oct 2018 8 May 2024§ | Sandoz | |
| Hulio (adalimumab-fkjp) | 6 Jul 2020 27 May 2025§ | Mylan/Biocon | |
| aflibercept | Ahzantive (aflibercept-mrbb) | 28-Jun-24 | Formycon/Klinge Pharma |
| Pavblu (aflibercept-ayyh) | 23-Aug-24 | Amgen | |
| Eydenzelt (aflibercept-boav) | 9-Oct-25 | Celltrion | |
| Enzeevu (aflibercept-abzv) | 12 Aug 2024# | Sandoz | |
| Opuviz (aflibercept-yszy) | 20 May 2024§ | Samsung Bioepis/Biogen | |
| Yesafili (aflibercept-jbvf) | 20 May 2024§ | Biocon | |
| bevacizumab | Mvasi (bevacizumab-awwb) | 14-Sep-17 | Amgen/Allergan |
| Zirabev (bevacizumab-bvzr) | 27-Jun-19 | Pfizer | |
| Alymsys (bevacizumab-maly) | 13-Apr-22 | Amneal Pharmaceuticals | |
| Vegzelma (bevacizumab-adcd) | 27-Sep-22 | Celltrion | |
| Avzivi (bevacizumab-tnjn) | 6-Dec-23 | Bio-Thera Solutions, marketed by Sandoz | |
| Jobevne (bevacizumab-nwgd) | 9-Apr-25 | Biocon | |
| denosumab | Osenvelt (denosumab-bmwo) see Stoboclo | 28-Feb-25 | Celltrion |
| Stoboclo (denosumab-bmwo) see Osenvelt | 28-Feb-25 | Celltrion | |
| Bomyntra (denosumab-bnht), see Conexxence | 25-Mar-25 | Fresenius Kabi | |
| Conexxence (denosumab-bnht), see Bomyntra | 25-Mar-25 | Fresenius Kabi | |
| Bildyos (denosumab-nxxp) | 29-Aug-25 | Henlius, marketed by Organon | |
| Bilprevda (denosumab-nxxp) | 29-Aug-25 | Henlius, marketed by Organon | |
| Aukelso (denosumab-kyqq) | 16-Sep-25 | Biocon | |
| Bosaya (denosumab-kyqq) | 16-Sep-25 | Biocon | |
| Enoby (denosumab-qbde) | 26-Sep-25 | Hikma | |
| Xtrenbo (denosumab-qbde) | 26-Sep-25 | Hikma | |
| Jubereq (denosumab-desu) see Osvyrti | 29-Oct-25 | Accord | |
| Osvyrti (denosumab-desu) see Jubereq | 29-Oct-25 | Accord | |
| Boncresa (denosumab-mobz) see Oziltus | 19-Dec-25 | Amneal Pharmaceuticals | |
| Oziltus (denosumab-mobz) see Boncresa | 19-Dec-25 | Amneal Pharmaceuticals | |
| Ospomyv (denosumab-dssb) see also Xbryk | 13 Feb 2025# | Samsung Bioepis | |
| Xbryk (denosumab-dssb) see also Ospomyv | 13 Feb 2025# | Samsung Bioepis | |
| Jubbonti (denosumab-bddz) see also Wyost | 5 Mar 2024§ | Sandoz | |
| Wyost (denosumab-bddz) see Jubbonti | 5 Mar 2024§ | Sandoz | |
| eculizumab | Epysqli (eculizumab-aagh) | 22-Jul-24 | Samsung Bioepis |
| Bkemv (eculizumab-aeeb) | 28 May 2024§ | Amgen | |
| Enoxaparin sodium | M-Enoxaparin§ | 23-Jul-10 | Momenta/Sandoz, India/Germany |
| Enoxaparin sodium§ | 14-Mar-19 | Amphastar Pharms | |
| epoetin alfa | Retacrit (epoetin alfa-epbx) | 15-May-18 | Pfizer (Hospira) |
| etanercept | Erelzi (etanercept-szzs) | 30-Aug-16 | Sandoz |
| Eticovo (etanercept-ykro) | 25-Apr-19 | Samsung Bioepis | |
| filgrastim | Zarxio (filgrastim-sndz) | 6-Mar-15 | Sandoz |
| Nivestym (filgrastim-aafi) | 20-Jul-18 | Pfizer (Hospira) | |
| Releuko (filgrastim-ayow) | 25-Feb-22 | Kashiv Biosciences (Amneal Pharmaceuticals) | |
| Releuko (filgrastim-ayow) | 25-Feb-22 | Kashiv Biosciences (Amneal Pharmaceuticals) | |
| Nypozi (filgrastim-txid) | 28-Jun-24 | Tanvex | |
| infliximab | Renflexis (infliximab-abda) | 21-Apr-17 | Samsung Bioepis/Merckk |
| Ixifi (infliximab-qbtx) | 13-Dec-17 | Pfizer | |
| Avsola (infliximab-axxq) | 6-Dec-19 | Amgen | |
| Zymfentra (infliximab-dyyb) see Inflectra | 23-Oct-23 | Celltrion | |
| Inflectra (infliximab-dyyb) see also Zymfentra | 5 Apr 2016 | Pfizer (Hospira) | |
| insulin aspart | Merilog (Insulin aspart-szjj) | 14-Feb-25 | Sanofi-Aventis |
| Kirsty ( (insulin aspart-xjhz) | 15 July 2025§ | Biocon | |
| insulin glargine | Basaglar# | 16-Dec-15 | Eli Lilly/ Boehringer Ingelheim |
| Lusduna# (tentative approval) | 20-Jul-17 | Merck Sharpe & Dohme | |
| Semglee (insulin glargine-yfgn) | 11 Jun 2020 28 Jul 2021§ | Biocon/Viatris (formerly Mylan) | |
| Rezvoglar (insulin glargine-aglr) | 17 Dec 2021§ | Eli Lilly | |
| insulin lispro | Admelog# | 11-Dec-17 | Sanofi |
| natalizumab | Tyruko (natalizumab-sztn) | 25-Aug-23 | Sandoz |
| omalizumab | Omlyclo (omalizumab-igec) | 7 Mar 2025§ | Celltrion Healthcare |
| pegfilgrastim | Fulphila (pegfilgrastim-jmdb) | 4-Jun-18 | Biocon/Mylan |
| Udenyca (pegfilgrastim-cbqv) | 2-Nov-18 | Coherus Biosciences | |
| Ziextenzo (pegfilgrastim-bmez) | 4-Nov-19 | Sandoz | |
| Nyvepria (pegfilgrastim-apgf) | 10-Jun-20 | Pfizer (Hospira) | |
| Fylnetra (pegfilgrastim-pbbk) | 26-May-22 | Kashiv Biosciences (Amneal Pharmaceuticals) | |
| Stimufend (pegfilgrastim-fpgk) | 1-Sep-22 | Fresenius Kabi | |
| Armlupeg (pegfilgrastim-unne) | 28-Nov-25 | Lupin | |
| Poherdy (pertuzumab-dpzb) | 13 Nov 2025§ | Shanghai Henlius | |
| ranibizumab | Byooviz (ranibizumab-runa) | 17 Sep 2021 Jun 2022§ | Samsung Bioepis |
| Cimerli (ranibizumab-eqrn) | 2 Aug 2022§ | Coherus Biosciences/22 Jan 2024 acquired by Sandoz | |
| rituximab | Truxima (rituximab-abbs) | 28-Nov-18 | Celltrion/Teva Pharmaceutical Industries |
| Ruxience (rituximab-pvvr) | 23-Jul-19 | Pfizer | |
| Riabni (rituximab-arrx) | 17-Dec-20 | Amgen | |
| teriparatide | PF708# (tentative approval) | 7-Oct-19 | Pfenex |
| tocilizumab | Tofidence (tocilizumab-bavi) | 29-Sep-23 | Bio-Thera Solutions, marketed by Biogen |
| Tyenne (tocilizumab-aazg) | 7-Mar-24 | Fresenius Kabi | |
| Avtozma (tocilizumab-anoh) | 24-Jan-25 | Celltrion | |
| trastuzumab | Ogivri (trastuzumab-dkst) | 1-Dec-17 | Biocon/Mylan |
| trastuzumab | Herzuma (trastuzumab-pkrb) | 14-Dec-18 | Celltrion/Teva Pharmaceutical Industries |
| Ontruzant (trastuzumab-dttb) | 18-Jan-19 | Samsung Bioepis/Merck | |
| Trazimera (trastuzumab-qyyp) | 11-Mar-19 | Pfizer | |
| Kanjinti (trastuzumab-anns) | 13-Jun-19 | Amgen | |
| Hercessi (trastuzumab-strf) | 29-Apr-24 | Henlius, marketed by Accord | |
| ustekinumab | Selarsdi (ustekinumab-aekn) | 16-Apr-24 | |
| Yesintek (ustekinumab-kfce) | 29-Nov-24 | Biocon | |
| Steqeyma (ustekinumab-stba) | 17-Dec-24 | Celltrion | |
| Starjemza (ustekinumab-hmny) | 22-May-25 | Bio-Thera Solutions, marketed by Sandoz | |
| Otulfi (ustekinumab-aauz) | 27 Sep 2024 19 May 2025§ | Fresenius Kabi/Formycon | |
| Wezlana (ustekinumab-auub) | 31 Oct 2023§ | Amgen | |
| Imuldosa (ustekinumab-srlf) | 10-Oct-24 | Accord | |
| Pyzchiva (ustekinumab-ttwe) | 28 Jun 2024# | Samsung Bioepis/Sandoz |
2026年1月29日