Armlupeg (pegfilgrastim-unne)November 2025Neulasta (pegfilgrastim) Poherdy (pertuzumab-dpzb)November 2025Perjeta (pertuzumab)Poherdy Information Osvyrti and Jubereq (denosumab-desu)October 2025Prolia and Xgeva (denosumab)Osvyrti and Jubereq Information Eydenzelt (aflibercept-boav)October 2025Eylea (aflibercept)Eydenzelt Information Enoby and Xtrenbo (denosumab-qbde)September 2025Prolia and Xgeva (denosumab)[Enoby and Xtrenbo Information](https://www.accessdata.fda.gov/scripts/cder/…
Armlupeg (pegfilgrastim-unne)November 2025Neulasta (pegfilgrastim) Poherdy (pertuzumab-dpzb)November 2025Perjeta (pertuzumab)Poherdy Information Osvyrti and Jubereq (denosumab-desu)October 2025Prolia and Xgeva (denosumab)Osvyrti and Jubereq Information Eydenzelt (aflibercept-boav)October 2025Eylea (aflibercept)Eydenzelt Information Enoby and Xtrenbo (denosumab-qbde)September 2025Prolia and Xgeva (denosumab)Enoby and Xtrenbo Information Aukelso and Bosaya (denosumab-kyqq)September 2025Prolia and Xgeva (denosumab)Aukelso and Bosaya Information Bildyos and Bilprevda (denosumab-nxxp)August 2025Prolia and Xgeva (denosumab)Bildyos and Bilprevda Information Kirsty (insulin aspart-xjhz)July 2025Novolog (insulin aspart)Kirsty Information Starjemza (ustekinumab-hmny)May 2025Stelara (ustekinumab)Starjemza Information Jobevne (bevacizumab-nwgd) April 2025Avastin (bevacizumab)Jobevne Information Bomyntra and Conexxence (denosumab-bnht)March 2025Prolia and Xgeva (denosumab)Bomyntra and Conexxence Information Omlyclo (omalizumab-igec)March 2025Xolair (omalizumab)Omlyclo Information Stoboclo and Osenvelt (denosumab-bmwo)February 2025Prolia and Xgeva (denosumab)Stoboclo and Osenvelt Information Merilog (insulin aspart-szjj)February 2025Novolog (insulin aspart)Merilog Information Ospomyv and Xbryk (denosumab-dssb)February 2025Prolia and Xgeva (denosumab)Ospomyv and Xbryk Information Avtozma (tocilizumab-anoh)January 2025Actemra (tocilizumab)Avtozma Information Steqeyma (Ustekinumab-stba)December 2024Stelara (ustekinumab)Steqeyma Information Yesintek (ustekinumab-kfce)November 2024Stelara (ustekinumab)Yesintek Information Imuldosa (ustekinumab-srlf)October 2024Stelara (ustekinumab)Imuldosa Information Otulfi (ustekinumab-aauz)September 2024Stelara (ustekinumab)Otulfi Information Pavblu (aflibercept-ayyh)August 2024Eylea (aflibercept)Pavblu Information Enzeevu (aflibercept-abzv) August 2024Eylea (aflibercept)Enzeevu Information Epysqli (eculizumab-aagh)July 2024Soliris (eculizumab)Epysqli Information Ahzantive (aflibercept-mrbb)June 2024Eylea (aflibercept)Ahzantive Information Nypozi (filgrastim-txid)June 2024Neupogen (filgrastim)Nypozi Information Pyzchiva (ustekinumab-ttwe)June 2024Stelara (ustekinumab)Pyzchiva Information Bkemv (eculizumab-aeeb)May 2024Soliris (eculizumab)Bkemv Information Press Release: FDA Approves First Interchangeable Biosimilar for Two Rare Diseases Yesafili (aflibercept-jbvf)May 2024Eylea (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 2024Eylea (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 2024Herceptin (trastuzumab)Hercessi Information Selarsdi (ustekinumab-aekn)April 2024Stelara (ustekinumab)Selarsdi Information Tyenne (tocilizumab-aazg) March 2024Actemra (tocilizumab)Tyenne Information Jubbonti and Wyost (denosumab-bbdz)March 2024Prolia 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 2024Humira (adalimumab)Simlandi Information Avzivi (bevacizumab-tnjn)December 2023Avastin (bevacizumab)Avzivi Information Wezlana (ustekinumab-auub)October 2023Stelara (ustekinumab)Wezlana Information Press Release: FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases Tofidence (tocilizumab-bavi)September 2023Actemra (tocilizumab)Tofidence Information CDER Notable Approval: FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis Tyruko (natalizumab-sztn)August 2023Tysabri (natalizumab)Tyruko Information Press Release: FDA Approves First Biosimilar to Treat Multiple Sclerosis Yuflyma (adalimumab-aaty)May 2023Humira (adalimumab)Yuflyma Information Idacio (adalimumab-aacf)December 2022Humira (adalimumab)Idacio Information Vegzelma (bevacizumab-adcd)September 2022Avastin (bevacizumab)Vegzelma Information Stimufend (pegfilgrastim-fpgk)September 2022Neulasta (pegfilgrastim)Stimufend Information Cimerli (ranibizumab-eqrn)August 2022Lucentis (ranibizumab) Cimerli Information Fylnetra (pegfilgrastim-pbbk)May 2022Neulasta (pegfilgrastim)Fylnetra Information Alymsys (bevacizumab-maly)April 2022Avastin (bevacizumab)Alymsys Information Releuko (filgrastim-ayow)February 2022Neupogen (filgrastim) Yusimry (adalimumab-aqvh)December 2021Humira (adalimumab) Yusimry Information Rezvoglar (insulin glargine-aglr)December 2021Lantus (insulin glargine)Rezvoglar Byooviz (ranibizumab-nuna)September 2021Lucentis (ranibizumab)Byooviz Information Press Release: FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions Semglee (Insulin glargine-yfgn)July 2021Lantus (Insulin glargine)Semglee Information Press Release: FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes Riabni (rituximab-arrx)December 2020Rituxan (rituximab)Riabni Information Hulio (adalimumab-fkjp)July 2020Humira (adalimumab)Hulio Information Nyvepria (pegfilgrastim-apgf)June 2020Neulasta (pegfilgrastim)Nyvepria Information Avsola (infliximab-axxq)December 2019Remicade (infliximab)Avsola Information Abrilada (adalimumab-afzb)November 2019Humira (adalimumab)Abrilada Information Ziextenzo (pegfilgrastim-bmez)November 2019Neulasta (pegfilgrastim)Ziextenzo Information Hadlima (adalimumab-bwwd)July 2019Humira (adalimumab)Hadlima Information Ruxience (rituximab-pvvr)July 2019Rituxan (rituximab)Ruxience Information Zirabev (bevacizumab-bvzrJune 2019Avastin (bevacizumab)Zirabev Information Kanjinti (trastuzumab-anns) June 2019Herceptin (trastuzumab)Kanjinti Information Eticovo (etanercept-ykro)April 2019Enbrel (etanercept)Eticovo Information Trazimera (trastuzumab-qyyp)March 2019Herceptin (trastuzumab)Trazimera Information Ontruzant (trastuzumab-dttb)January 2019Herceptin (trastuzumab)Ontruzant Information Herzuma (trastuzumab-pkrb) December 2018Herceptin (trastuzumab)Herzuma Information Truxima (rituximab-abbs)November 2018Rituxan (rituximab)Truxima Information Press Release: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma Udenyca (pegfilgrastim-cbqv) November 2018Neulasta (pegfilgrastim)Udenyca Information Hyrimoz (adalimumab-adaz)October 2018Humira (adalimumab)Hyrimoz Information Nivestym (filgrastim-aafi)July 2018Neupogen (filgrastim)Nivestym Information Fulphila (pegfilgrastim-jmdb)June 2018Neluasta (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 2018Epogen (epoetin-alfa)Retacrit information Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia Ixifi (infliximab-qbtx)December 2017Remicade (infliximab)Ixifi information Ogivri (trastuzumab-dkst)December 2017Herceptin (trastuzumab)Ogivri information Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers Mvasi (Bevacizumab-awwb)September 2017Avastin (bevacizumab)Mvasi information Press Release: FDA approves first biosimilar for the treatment of cancer Cyltezo (Adalimumab-adbm)August 2017Humira (adalimumab)Cyltezo information Renflexis (Infliximab-abda)May 2017Remicade (infliximab)Renflexis information Amjevita (Adalimumab -atto)September 2016Humira (adalimumab)Amjevita information Press Release: FDA approves Amjevita Erelzi (Etanercept-szzs)August 2016Enbrel (etanercept)Erelzi information Press Release: FDA approves Erelzi Inflectra (Infliximab-dyyb)April 2016Remicade (infliximab)Inflectra information Press Release: FDA approves Inflectra Zarxio (Filgrastim-sndz)March 2015Neupogen (filgrastim)Zarxio information