Biosimilar Product Information
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.
FDA-Approved Biosimilar Products
| Biosimilar Name | Approval Date | Reference Product | More 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 |
| 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 |
Learn More
The Purple Book Database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products.
The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).