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  8. Biosimilar Product Information
  1. Biosimilars

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
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).

 
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