The Food and Drug Administration approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.
| Biosimilar Name | Approval Date | Reference Product | More Information |
| Osvyrti and Jubereq (denosumab-desu) | Oct-25 | Prolia and Xgeva (denosumab) | |
| Eydenzelt (aflibercept-boav) | Oct-25 | Eylea (aflibercept) | Eydenzelt Information |
| Enoby and Xtrenbo (denosumab-qbde) | Sep-25 | Prolia and Xgeva (denosumab) | Enoby and Xtrenbo Information |
| Aukelso and Bosaya (denosumab-kyqq) | Sep-25 | Prolia and Xgeva (denosumab) | Aukelso and Bosaya Information |
| Bildyos and Bilprevda (denosumab-nxxp) | Aug-25 | Prolia and Xgeva (denosumab) | Bildyos and Bilprevda Information |
| Kirsty (insulin aspart-xjhz) | Jul-25 | Novolog (insulin aspart) | Kirsty Information |
| Starjemza (ustekinumab-hmny) | May-25 | Stelara (ustekinumab) | Starjemza Information |
| Jobevne (bevacizumab-nwgd) | Apr-25 | Avastin (bevacizumab) | Jobevne Information |
| Bomyntra and Conexxence (denosumab-bnht) | Mar-25 | Prolia and Xgeva (denosumab) | Bomyntra and Conexxence Information |
| Omlyclo (omalizumab-igec) | Mar-25 | Xolair (omalizumab) | Omlyclo Information |
| Stoboclo and Osenvelt (denosumab-bmwo) | Feb-25 | Prolia and Xgeva (denosumab) | Stoboclo and Osenvelt Information |
| Merilog (insulin aspart-szjj) | Feb-25 | Novolog (insulin aspart) | Merilog Information |
| Ospomyv and Xbryk (denosumab-dssb) | Feb-25 | Prolia and Xgeva (denosumab) | Ospomyv and Xbryk Information |
| Avtozma (tocilizumab-anoh) | Jan-25 | Actemra (tocilizumab) | Avtozma Information |
| Steqeyma (Ustekinumab-stba) | Dec-24 | Stelara (ustekinumab) | Steqeyma Information |
| Yesintek (ustekinumab-kfce) | Nov-24 | Stelara (ustekinumab) | Yesintek Information |
| Imuldosa (ustekinumab-srlf) | Oct-24 | Stelara (ustekinumab) | Imuldosa Information |
| Otulfi (ustekinumab-aauz) | Sep-24 | Stelara (ustekinumab) | Otulfi Information |
| Pavblu (aflibercept-ayyh) | Aug-24 | Eylea (aflibercept) | Pavblu Information |
| Enzeevu (aflibercept-abzv) | Aug-24 | Eylea (aflibercept) | Enzeevu Information |
| Epysqli (eculizumab-aagh) | Jul-24 | Soliris (eculizumab) | Epysqli Information |
| Ahzantive (aflibercept-mrbb) | Jun-24 | Eylea (aflibercept) | Ahzantive Information |
| Nypozi (filgrastim-txid) | Jun-24 | Neupogen (filgrastim) | Nypozi Information |
| Pyzchiva (ustekinumab-ttwe) | Jun-24 | Stelara (ustekinumab) | Pyzchiva Information |
| Bkemv (eculizumab-aeeb) | May-24 | Soliris (eculizumab) | Bkemv Information |
| Press Release: FDA Approves First Interchangeable Biosimilar for Two Rare Diseases | |||
| Yesafili (aflibercept-jbvf) | May-24 | 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-24 | 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) | Apr-24 | Herceptin (trastuzumab) | Hercessi Information |
| Selarsdi (ustekinumab-aekn) | Apr-24 | Stelara (ustekinumab) | Selarsdi Information |
| Tyenne (tocilizumab-aazg) | Mar-24 | Actemra (tocilizumab) | Tyenne Information |
| Jubbonti and Wyost (denosumab-bbdz) | Mar-24 | 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) | Feb-24 | Humira (adalimumab) | Simlandi Information |
| Avzivi (bevacizumab-tnjn) | Dec-23 | Avastin (bevacizumab) | Avzivi Information |
| Wezlana (ustekinumab-auub) | Oct-23 | Stelara (ustekinumab) | Wezlana Information |
| Press Release: FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases | |||
| Tofidence (tocilizumab-bavi) | Sep-23 | Actemra (tocilizumab) | Tofidence Information |
| CDER Notable Approval: FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis | |||
| Tyruko (natalizumab-sztn) | Aug-23 | Tysabri (natalizumab) | Tyruko Information |
| Press Release: FDA Approves First Biosimilar to Treat Multiple Sclerosis | |||
| Yuflyma (adalimumab-aaty) | May-23 | Humira (adalimumab) | Yuflyma Information |
| Idacio (adalimumab-aacf) | Dec-22 | Humira (adalimumab) | Idacio Information |
| Vegzelma (bevacizumab-adcd) | Sep-22 | Avastin (bevacizumab) | Vegzelma Information |
| Stimufend (pegfilgrastim-fpgk) | Sep-22 | Neulasta (pegfilgrastim) | Stimufend Information |
| Cimerli (ranibizumab-eqrn) | Aug-22 | Lucentis (ranibizumab) | Cimerli Information |
| Fylnetra (pegfilgrastim-pbbk) | May-22 | Neulasta (pegfilgrastim) | Fylnetra Information |
| Alymsys (bevacizumab-maly) | Apr-22 | Avastin (bevacizumab) | Alymsys Information |
| Releuko (filgrastim-ayow) | Feb-22 | Neupogen (filgrastim) | |
| Yusimry (adalimumab-aqvh) | Dec-21 | Humira (adalimumab) | Yusimry Information |
| Rezvoglar | Dec-21 | Lantus (insulin glargine) | Rezvoglar |
| (insulin glargine-aglr) | |||
| Byooviz | Sep-21 | Lucentis (ranibizumab) | Byooviz Information |
| (ranibizumab-nuna) | Press Release: FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions | ||
| Semglee | Jul-21 | Lantus (Insulin glargine) | Semglee Information |
| (Insulin glargine-yfgn) | Press Release: FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes | ||
| Riabni | Dec-20 | Rituxan (rituximab) | Riabni Information |
| (rituximab-arrx) | |||
| Hulio | Jul-20 | Humira (adalimumab) | Hulio Information |
| (adalimumab-fkjp) | |||
| Nyvepria | Jun-20 | Neulasta (pegfilgrastim) | Nyvepria Information |
| (pegfilgrastim-apgf) | |||
| Avsola | Dec-19 | Remicade (infliximab) | Avsola Information |
| (infliximab-axxq) | |||
| Abrilada | Nov-19 | Humira (adalimumab) | Abrilada Information |
| (adalimumab-afzb) | |||
| Ziextenzo | Nov-19 | Neulasta (pegfilgrastim) | Ziextenzo Information |
| (pegfilgrastim-bmez) | |||
| Hadlima | Jul-19 | Humira (adalimumab) | Hadlima Information |
| (adalimumab-bwwd) | |||
| Ruxience | Jul-19 | Rituxan (rituximab) | Ruxience Information |
| (rituximab-pvvr) | |||
| Zirabev | Jun-19 | Avastin (bevacizumab) | Zirabev Information |
| (bevacizumab-bvzr | |||
| Kanjinti | Jun-19 | Herceptin (trastuzumab) | Kanjinti Information |
| (trastuzumab-anns) | |||
| Eticovo | Apr-19 | Enbrel (etanercept) | Eticovo Information |
| (etanercept-ykro) | |||
| Trazimera | Mar-19 | Herceptin (trastuzumab) | Trazimera Information |
| (trastuzumab-qyyp) | |||
| Ontruzant | Jan-19 | Herceptin (trastuzumab) | Ontruzant Information |
| (trastuzumab-dttb) | |||
| Herzuma | Dec-18 | Herceptin (trastuzumab) | Herzuma Information |
| (trastuzumab-pkrb) | |||
| Truxima | Nov-18 | Rituxan (rituximab) | Truxima Information |
| (rituximab-abbs) | Press Release: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma | ||
| Udenyca | Nov-18 | Neulasta (pegfilgrastim) | Udenyca Information |
| (pegfilgrastim-cbqv) | |||
| Hyrimoz | Oct-18 | Humira (adalimumab) | Hyrimoz Information |
| (adalimumab-adaz) | |||
| Nivestym | Jul-18 | Neupogen (filgrastim) | Nivestym Information |
| (filgrastim-aafi) | |||
| Fulphila | Jun-18 | Neluasta (pegfilgrastim) | Fulphila Information |
| (pegfilgrastim-jmdb) | Press Release: FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment | ||
| Retacrit | May-18 | Epogen (epoetin-alfa) | Retacrit information |
| (epoetin alfa-epbx) | Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia | ||
| Ixifi (infliximab-qbtx) | Dec-17 | Remicade (infliximab) | Ixifi information |
| Ogivri | Dec-17 | Herceptin (trastuzumab) | Ogivri information |
| (trastuzumab-dkst) | Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers | ||
| Mvasi | Sep-17 | Avastin (bevacizumab) | Mvasi information |
| (Bevacizumab-awwb) | Press Release: FDA approves first biosimilar for the treatment of cancer | ||
| Cyltezo | Aug-17 | Humira (adalimumab) | Cyltezo information |
| (Adalimumab-adbm) | |||
| Renflexis (Infliximab-abda) | May-17 | Remicade (infliximab) | Renflexis information |
| Amjevita | Sep-16 | Humira (adalimumab) | Amjevita information |
| (Adalimumab -atto) | Press Release: FDA approves Amjevita | ||
| Erelzi | Aug-16 | Enbrel (etanercept) | Erelzi information |
| (Etanercept-szzs) | Press Release: FDA approves Erelzi | ||
| Inflectra | Apr-16 | Remicade (infliximab) | Inflectra information |
| (Infliximab-dyyb) | Press Release: FDA approves Inflectra | ||
| Zarxio | Mar-15 | Neupogen (filgrastim) | Zarxio information |
| (Filgrastim-sndz) |
Source form FDA
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