Generics and Biosimilars Initiatives (GaBI）onlineが2025年5月22日までに米国で承認されたバイオシミラーをまとめている。同誌は、2024年7月にも同年7月までの承認品目をまとめている（参考：米国で承認されたバイオシミラー、7月24日アップ）。
2025年4月末までにFDAは、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α（TNF-α）、5）血管内皮増殖因子（VEGF）阻害剤の製品クラス内で75 バイオシミラーを承認している。（昨年7月までの承認数は56。クラスには追加はない）。また、これらのうち21 が互換性のあるバイオシミラーとして承認されている（同13品目）。
なお、2025年4月末までに、FDAは合計81 バイオシミラーを承認しており、その中には6のフォローオン生物学的製剤が含まれているが、これらは米国での使用のためにBLA 351Kプロセスを経ていない（昨年7月末まででは、58のバイオシミラーと6のフォローオン製剤）。Omnitrope (Sandoz)とValtropin (LG Life Sciences, Biopartners)の2つのsomatropinは、2007年にFDAからタンパク質製剤の後続品follow-on protein productとして承認されている。
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?utm_source=BenchmarkEmail&utm_campaign=GONL_V25E22-24&utm_medium=email
FDA approved biosimilars*
| Active substance | Product name | Manufacturer/ Company name | Authorization date |
| adalimumab | Abrilada (adalimumab-afzb) | Pfizer | 2019/11/15 5 Oct 2023§ |
| Amjevita (adalimumab-atto) | Amgen | 23-Sep-16 | |
| Cyltezo (adalimumab-adbm) | Boehringer Ingelheim | 2017/8/25 15 Oct 2021§ | |
| Hadlima (adalimumab-bwwd) | Samsung Bioepis | 23-Jul-19 | |
| Hulio (adalimumab-fkjp) | Mylan/Biocon | 6-Jul-20 | |
| Hyrimoz (adalimumab-adaz) | Sandoz | 2018/10/30 8 May 2024§ | |
| Idacio (adalimumab-aacf) | Fresenius Kabi | 13-Dec-22 | |
| Simlandi (adalimumab-ryvk) | Alvotech, marketed by Teva | 23 Feb 2024§ | |
| Yuflyma (adalimumab-aaty) | Celltrion | May-23 | |
| Yusimry (adalimumab-aqvh) | Coherus Biosciences/27 June 2024 acquied by Hong Kong King-Friend Industrial | 17-Dec-21 | |
| aflibercept | Ahzantive (aflibercept-mrbb) | Formycon/Klinge Pharma | 28-Jun-24 |
| Enzeevu (aflibercept-abzv) | Sandoz | 12 Aug 2024# | |
| Opuviz (aflibercept-yszy) | Samsung Bioepis/Biogen | 20 May 2024§ | |
| Pavblu (aflibercept-ayyh) | Amgen | 23-Aug-24 | |
| Yesafili (aflibercept-jbvf) | Biocon | 20 May 2024§ | |
| bevacizumab | Alymsys (bevacizumab-maly) | Amneal Pharmaceuticals | 13-Apr-22 |
| Avzivi (bevacizumab-tnjn) | Bio-Thera Solutions, marketed by Sandoz | 6-Dec-23 | |
| Jobevne (bevacizumab-nwgd) | Biocon | 9-Apr-25 | |
| Mvasi (bevacizumab-awwb) | Amgen/Allergan | 14-Sep-17 | |
| Vegzelma (bevacizumab-adcd) | Celltrion | 27-Sep-22 | |
| Zirabev (bevacizumab-bvzr) | Pfizer | 27-Jun-19 | |
| denosumab | Bomyntra (denosumab-bnht), see Conexxence | Fresenius Kabi | 25-Mar-25 |
| Conexxence (denosumab-bnht), see Bomyntra | Fresenius Kabi | 25-Mar-25 | |
| Jubbonti (denosumab-bddz) see also Wyost | Sandoz | 5 Mar 2024§ | |
| Ospomyv (denosumab-dssb) see also Xbryk | Samsung Bioepis | 13 Feb 2025# | |
| Wyost (denosumab-bddz) see also Jubbonti | Sandoz | 5 Mar 2024§ | |
| Xbryk (denosumab-dssb) see also Ospomyv | Samsung Bioepis | 13 Feb 2025# | |
| eculizumab | Bekemv (eculizumab-aeeb) | Amgen | 28 May 2024§ |
| Epysqli (eculizumab-aagh) | Samsung Bioepis | 22-Jul-24 | |
| epoetin alfa | Retacrit (epoetin alfa-epbx) | Pfizer (Hospira) | 15-May-18 |
| etanercept | Erelzi (etanercept-szzs) | Sandoz | 30-Aug-16 |
| Eticovo (etanercept-ykro) | Samsung Bioepis | 25-Apr-19 | |
| filgrastim | Nivestym (filgrastim-aafi) | Pfizer (Hospira) | 20-Jul-18 |
| Nypozi (filgrastim-txid) | Tanvex | 28-Jun-24 | |
| Releuko (filgrastim-ayow) | Kashiv Biosciences (Amneal Pharmaceuticals) | 25-Feb-22 | |
| Releuko (filgrastim-ayow) | Kashiv Biosciences (Amneal Pharmaceuticals) | 25-Feb-22 | |
| Zarxio(filgrastim-sndz) | Sandoz | 6-Mar-15 | |
| infliximab | Avsola (infliximab-axxq) | Amgen | 6-Dec-19 |
| Inflectra (infliximab-dyyb) see also Zymfentra | Pfizer (Hospira) | 5 Apr 2016 | |
| Ixifi (infliximab-qbtx) | Pfizer | 13-Dec-17 | |
| Renflexis (infliximab-abda) | Samsung Bioepis/Merckk | 21-Apr-17 | |
| Zymfentra (infliximab-dyyb) see also Inflectra | Celltrion | 23-Oct-23 | |
| insulin aspart | Merilog (Insulin aspart-szjj) | Sanofi-Aventis | 14-Feb-25 |
| insulin glargine | Rezvoglar (insulin glargine-aglr) | Eli Lilly | 17 Dec 2021§ |
| Semglee (insulin glargine-yfgn) | Biocon/Viatris (formerly Mylan) | 2020/6/11 28 Jul 2021§ | |
| natalizumab | Tyruko (natalizumab-sztn) | Sandoz | 25-Aug-23 |
| omalizumab | Omlyclo (omalizumab-igec) | Celltrion Healthcare | 7 Mar 2025§ |
| pegfilgrastim | Fulphila (pegfilgrastim-jmdb) | Biocon/Mylan | 4-Jun-18 |
| Fylnetra (pegfilgrastim-pbbk) | Kashiv Biosciences (Amneal Pharmaceuticals) | 26-May-22 | |
| Nyvepria (pegfilgrastim-apgf) | Pfizer (Hospira) | 10-Jun-20 | |
| Udenyca (pegfilgrastim-cbqv) | Coherus Biosciences | 2-Nov-18 | |
| Ziextenzo (pegfilgrastim-bmez) | Sandoz | 4-Nov-19 | |
| Stimufend (pegfilgrastim-fpgk) | Fresenius Kabi | 1-Sep-22 | |
| ranibizumab | Byooviz (ranibizumab-runa) | Samsung Bioepis | 2021/9/17 Jun 2022§ |
| Cimerli (ranibizumab-eqrn) | Coherus Biosciences/22 Jan 2024 acquired by Sandoz | 2 Aug 2022§ | |
| rituximab | Riabni(rituximab-arrx) | Amgen | 17-Dec-20 |
| Ruxience (rituximab-pvvr) | Pfizer | 23-Jul-19 | |
| Truxima (rituximab-abbs) | Celltrion/Teva Pharmaceutical Industries | 28-Nov-18 | |
| tocilizumab | Avtozma (tocilizumab-anoh) | Celltrion | 24-Jan-25 |
| Tofidence (tocilizumab-bavi) | Bio-Thera Solutions, marketed by Biogen | 29-Sep-23 | |
| Tyenne (tocilizumab-aazg) | Fresenius Kabi | 7-Mar-24 | |
| trastuzumab | Hercessi (trastuzumab-strf) | Henlius, marketed by Accord | 29-Apr-24 |
| Herzuma (trastuzumab-pkrb) | Celltrion/Teva Pharmaceutical Industries | 14-Dec-18 | |
| Kanjinti (trastuzumab-anns) | Amgen | 13-Jun-19 | |
| Ogivri (trastuzumab-dkst) | Biocon/Mylan | 1-Dec-17 | |
| Ontruzant (trastuzumab-dttb) | Samsung Bioepis/Merck | 18-Jan-19 | |
| Trazimera (trastuzumab-qyyp) | Pfizer | 11-Mar-19 | |
| ustekinumab | Otulfi (ustekinumab-aauz) | Fresenius Kabi/Formycon | 2024/9/27 19 May 2025§ |
| Selarsdi (ustekinumab-aekn) | 16-Apr-24 | ||
| Steqeyma (ustekinumab-stba) | Celltrion | 17-Dec-24 | |
| Wezlana (ustekinumab-auub) | Amgen | 31 Oct 2023§ | |
| Yesintek (ustekinumab-kfce) | Biocon | 29-Nov-24 | |
| Imuldosa (ustekinumab-srlf) | Accord | 10-Oct-24 | |
| Pyzchiva (ustekinumab-ttwe) | Samsung Bioepis/Sandoz | 28 Jun 2024# |
*データは2025年5月22日更新
§互換性のあるバイオシミラーとして承認された日。
#互換性に関する仮決定
infliximab-dyybは、 Inflectra (Pfizer) が2016年に、Zymfentra (Celltrion) が2023年に、 2つのブランド 名で承認された。 2つのブランド名で承認された他のバイオシミラーは以下の通り：
- Denosumab-bddz (Sandoz): Jubbonti and Wyost, approved on 5 March 2024.
- Denosumab-dssb (Samsung Bioepis): Ospomyv and Xbryk/SB16, approved on 13 February 2025.
- Denosumab-bmwo (Celltrion): Osenvelt and Stoboclo, approved on 28 February 2025
- Denosumab-bnht (Fresenius Kabi): Bomyntra and Conexxence, approved on 25 March 2025
Overview of biosimilars and interchangeable biosimilars approved by FDA*
| Approved biosimilars | |||
| Brand name | Active substance | Total no. approved | Interchangeable designation |
| Humira | adalimumab | 10 | 4 |
| Eylea | aflibercept | 5 | 3 |
| Avastin | bevacizumab | 6 | |
| Prolia & Xgeva | denosumab | 8 | 4 |
| Soliris | eculizumab | 2 | 1 |
| Epogen/Procrit | epoetin alfa | 1 | |
| Enbrel | etanercept | 2 | |
| Neupogen | filgrastim | 4 | |
| Remicade | infliximab | 5 | |
| NovoLog | insulin aspart | 1 | |
| Lantus | insulin glargine | 2 | 2 |
| Tysabri | natalizumab | 1 | |
| Xolair | omalizumab | 1 | 1 |
| Neulasta | pegfilgrastim | 6 | |
| Lucentis | ranibizumab | 2 | 2 |
| Rituxan | rituximab | 3 | |
| Actemra | tocilizumab | 3 | |
| Herceptin | trastuzumab | 6 | |
| Stelara | ustekinumab | 7 | 4 |
| TOTAL | 75 | 2 | |
*2025年5月22日更新
2025年5月23日