| 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 |
| Tyenne (tocilizumab-aazg) |
March 2024 |
Actemra (tocilizumab) |
Tyenne 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 |
| Wezlana (ustekinumab-auub) |
October 2023 |
Stelara (ustekinumab) |
Wezlana Information
Press Release: FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases |
| Tofidence (tocilizumab-bavi) |
September 2023 |
Actemra (tocilizumab) |
Tofidence Information
CDER Notable Approval: FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis |
| Tyruko (natalizumab-sztn) |
August 2023 |
Tysabri (natalizumab) |
Tyruko Information
Press Release: FDA Approves First Biosimilar to Treat Multiple Sclerosis |
| 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 |
Eticovo
(etanercept-ykro) |
April 2019 |
Enbrel (etanercept) |
Eticovo 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 |
Erelzi
(Etanercept-szzs) |
August 2016 |
Enbrel (etanercept) |
Erelzi information
Press Release: FDA approves Erelzi |
Inflectra
(Infliximab-dyyb) |
April 2016 |
Remicade (infliximab) |
Inflectra information
Press Release: FDA approves Inflectra |
Zarxio
(Filgrastim-sndz) |
March 2015 |
Neupogen (filgrastim) |
Zarxio information |
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