Approved Biosimilars
The Food and Drug Administration (FDA) has approved 75 biosimilars. Below are lists of all approved biosimilars divided into those that are on the market and those that are not on the market yet.
More information available via the FDA’s Purple Book. This is a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act.
Currently, the searchable database contains information about all FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products, and their reference products, and FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER.
Biosimilars Approved and on the Market Approval Date Reference Product More Information
| Biosimilar Name | Approval Date | Reference Product | More Information |
|---|---|---|---|
| Osvyrti and Jubereq (denosumab-desu) | October 2025 | Prolia and Xgeva (denosumab) | |
| Eydenzelt (aflibercept-boav) | October 2025 | Eylea (aflibercept) | Eydenzelt Information |
| Enoby and Xtrenbo (denosumab-qbde) | September 2025 | Prolia and Xgeva (denosumab) | Enoby and Xtrenbo Information |
| Aukelso and Bosaya (denosumab-kyqq) | September 2025 | Prolia and Xgeva (denosumab) | Aukelso and Bosaya Information |
| Bildyos and Bilprevda (denosumab-nxxp) | August 2025 | Prolia and Xgeva (denosumab) | Bildyos and Bilprevda Information |
| Kirsty (insulin aspart-xjhz) | July 2025 | Novolog (insulin aspart) | Kirsty Information |
| Starjemza (ustekinumab-hmny) | May 2025 | Stelara (ustekinumab) | Starjemza Information |
| Jobevne (bevacizumab-nwgd) | April 2025 | Avastin (bevacizumab) | Jobevne Information |
| Bomyntra and Conexxence (denosumab-bnht) | March 2025 | Prolia and Xgeva (denosumab) | Bomyntra and Conexxence Information |
| Omlyclo (omalizumab-igec) | March 2025 | Xolair (omalizumab) | Omlyclo Information |
| Stoboclo and Osenvelt (denosumab-bmwo) | February 2025 | Prolia and Xgeva (denosumab) | Stoboclo and Osenvelt Information |
| Merilog (insulin aspart-szjj) | February 2025 | Novolog (insulin aspart) | Merilog Information |
| Ospomyv and Xbryk (denosumab-dssb) | February 2025 | Prolia and Xgeva (denosumab) | Ospomyv and Xbryk Information |
| Avtozma (tocilizumab-anoh) | January 2025 | Actemra (tocilizumab) | Avtozma Information |
| Steqeyma (Ustekinumab-stba) | December 2024 | Stelara (ustekinumab) | Steqeyma Information |
| Yesintek (ustekinumab-kfce) | November 2024 | Stelara (ustekinumab) | Yesintek Information |
| Imuldosa (ustekinumab-srlf) | October 2024 | Stelara (ustekinumab) | Imuldosa Information |
| Otulfi (ustekinumab-aauz) | September 2024 | Stelara (ustekinumab) | Otulfi Information |
| Pavblu (aflibercept-ayyh) | August 2024 | Eylea (aflibercept) | Pavblu Information |
| Enzeevu (aflibercept-abzv) | August 2024 | Eylea (aflibercept) | Enzeevu Information |
| Epysqli (eculizumab-aagh) | July 2024 | Soliris (eculizumab) | Epysqli Information |
| Ahzantive (aflibercept-mrbb) | June 2024 | Eylea (aflibercept) | Ahzantive Information |
| Nypozi (filgrastim-txid) | June 2024 | Neupogen (filgrastim) | Nypozi Information |
| Pyzchiva (ustekinumab-ttwe) | June 2024 | Stelara (ustekinumab) | Pyzchiva Information |
| Bkemv (eculizumab-aeeb) | May 2024 | Soliris (eculizumab) | Bkemv Information Press Release: FDA Approves First Interchangeable Biosimilar for Two Rare Diseases |
| Yesafili (aflibercept-jbvf) | May 2024 | Eylea (aflibercept) | Yesafili Information CDER Notable Approval: FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions |
| Opuviz (aflibercept-yszy) | May 2024 | Eylea (aflibercept) | Opuviz Information CDER Notable Approval: FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions |
| Hercessi (trastuzumab-strf) | April 2024 | Herceptin (trastuzumab) | Hercessi Information |
| Selarsdi (ustekinumab-aekn) | April 2024 | Stelara (ustekinumab) | Selarsdi Information |
| Jubbonti and Wyost (denosumab-bbdz) | March 2024 | Prolia and Xgeva (denosumab) | Jubbonti and Wyost Information CDER Notable Approval: FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer |
| Simlandi (adalimumab-ryvk) | February 2024 | Humira (adalimumab) | Simlandi Information |
| Avzivi (bevacizumab-tnjn) | December 2023 | Avastin (bevacizumab) | Avzivi Information |
| Yuflyma (adalimumab-aaty) | May 2023 | Humira (adalimumab) | Yuflyma Information |
| Idacio (adalimumab-aacf) | December 2022 | Humira (adalimumab) | Idacio Information |
| Vegzelma (bevacizumab-adcd) | September 2022 | Avastin (bevacizumab) | Vegelma Information |
| Stimufend (pegfilgrastim-fpgk) | September 2022 | Neulasta (pegfilgrastim) | Stimufend Information |
| Cimerli (ranibizumab-eqrn) | August 2022 | Lucentis (ranibizumab) | Cimerli Information |
| Fylnetra (pegfilgrastim-pbbk) | May 2022 | Neulasta (pegfilgrastim) | Fylnetra Information |
| Alymsys (bevacizumab-maly) | April 2022 | Avastin (bevacizumab) | Alymsys Information |
| Releuko (filgrastim-ayow) | February 2022 | Neupogen (filgrastim) | |
| Yusimry (adalimumab-aqvh) | December 2021 | Humira (adalimumab) | Yusimry Information |
| Rezvoglar (insulin glargine-aglr) | December 2021 | Lantus (insulin glargine) | Rezvoglar |
| Byooviz (ranibizumab-nuna) | September 2021 | Lucentis (ranibizumab) | Byooviz Information Press Release: FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions |
| Semglee (Insulin glargine-yfgn) | July 2021 | Lantus (Insulin glargine) | Semglee Information Press Release: FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes |
| Riabni (rituximab-arrx) | December 2020 | Rituxan (rituximab) | Riabni Information |
| Hulio (adalimumab-fkjp) | July 2020 | Humira (adalimumab) | Hulio Information |
| Nyvepria (pegfilgrastim-apgf) | June 2020 | Neulasta (pegfilgrastim) | Nyvepria Information |
| Avsola (infliximab-axxq) | December 2019 | Remicade (infliximab) | Avsola Information |
| Abrilada (adalimumab-afzb) | November 2019 | Humira (adalimumab) | Abrilada Information |
| Ziextenzo (pegfilgrastim-bmez) | November 2019 | Neulasta (pegfilgrastim) | Ziextenzo Information |
| Hadlima (adalimumab-bwwd) | July 2019 | Humira (adalimumab) | Hadlima Information |
| Ruxience (rituximab-pvvr) | July 2019 | Rituxan (rituximab) | Ruxience Information |
| Zirabev (bevacizumab-bvzr) | June 2019 | Avastin (bevacizumab) | Zirabev Information |
| Kanjinti (trastuzumab-anns) | June 2019 | Herceptin (trastuzumab) | Kanjinti Information |
| Trazimera (trastuzumab-qyyp) | March 2019 | Herceptin (trastuzumab) | Trazimera Information |
| Ontruzant (trastuzumab-dttb) | January 2019 | Herceptin (trastuzumab) | Ontruzant Information |
| Herzuma (trastuzumab-pkrb) | December 2018 | Herceptin (trastuzumab) | Herzuma Information |
| Truxima (rituximab-abbs) | November 2018 | Rituxan (rituximab) | Truxima Information Press Release: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma |
| Udenyca (pegfilgrastim-cbqv) | November 2018 | Neulasta (pegfilgrastim) | Udenyca Information |
| Hyrimoz (adalimumab-adaz) | October 2018 | Humira (adalimumab) | Hyrimoz Information |
| Nivestym (filgrastim-aafi) | July 2018 | Neupogen (filgrastim) | Nivestym Information |
| Fulphila (pegfilgrastim-jmdb) | June 2018 | Neluasta (pegfilgrastim) | Fulphila Information Press Release: FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment |
| Retacrit (epoetin alfa-epbx) | May 2018 | Epogen (epoetin-alfa) | Retacrit information Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia |
| Ixifi (infliximab-qbtx) | December 2017 | Remicade (infliximab) | Ixifi information |
| Ogivri (trastuzumab-dkst) | December 2017 | Herceptin (trastuzumab) | Ogivri information Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers |
| Mvasi (Bevacizumab-awwb) | September 2017 | Avastin (bevacizumab) | Mvasi information Press Release: FDA approves first biosimilar for the treatment of cancer |
| Cyltezo (Adalimumab-adbm) | August 2017 | Humira (adalimumab) | Cyltezo information |
| Renflexis (Infliximab-abda) | May 2017 | Remicade (infliximab) | Renflexis information |
| Amjevita (Adalimumab -atto) | September 2016 | Humira (adalimumab) | Amjevita information Press Release: FDA approves Amjevita |
| Inflectra (Infliximab-dyyb) | April 2016 | Remicade (infliximab) | Inflectra information Press Release: FDA approves Inflectra |
| Zarxio (Filgrastim-sndz) | March 2015 | Neupogen (filgrastim) | Zarxio information |
Biosimilars Approved, but not on the Market Yet
| Tofidence (tocilizumab-bavi) | September 2023 | Actemra (tocilizumab) | Tofidence Information |
| Tyruko (natalizumab-sztn) | August 2023 | Tysabri (natalizumab) | Tyruko Information |
| Eticovo (etanercept-ykro) | April 2019 | Enbrel (etanercept) | Eticovo Information |
| Erelzi (Etanercept-szzs) | August 2016 | Enbrel (etanercept) | Erelzi information Press Release: FDA approves Erelzi |