BIOSIMILAR APPROVAL STATUS IN THE US: FDA FILING DATES AND ACTIONS
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Biosimilar
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Manufacturer
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Brand Name & Designation
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Innovator Product
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FDA Filing Date
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Status
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Epoetin
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Pfizer (Hospira)
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Retacrit (epoetin-epbx)
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Epogen
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December 16, 2014
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Approved May 15, 2018
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Filgrastim
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Sandoz
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Zarxio (filgrastim-sndz)
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Neupogen
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May 8, 2014
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Approved March 6, 2015; marketed
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Filgrastim
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Apotex
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TBD
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Neupogen
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February 13, 2015
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No FDA action reported (Complete response letter issued?)
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Infliximab
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Celltrion/Pfizer
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Inflectra (infliximab-dyyb)
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Remicade
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August 8, 2014
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Approved April 5, 2016; marketed
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Infliximab
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Samsung Bioepis/Merck
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Renflexis (infliximab-abda)
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Remicade
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May 23, 2016
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Approved April 21, 2017; marketed
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Infliximab
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Pfizer
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Ixifi (infliximab-qbtx)
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Remicade
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April 2017
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Approved December 14, 2017, all indications; will not be marketed in US
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Etanercept
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Sandoz
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Erelzi (etanercept-szzs)
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Enbrel
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October 2, 2015
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Approved August 31, 2016, all indications; not yet marketed
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Adalimumab
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Amgen
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Amjevita (adalimumab-atto)
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Humira
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November 25, 2015
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Approved September 23, 2016, all indications; not yet marketed
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Pegfilgrastim
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Sandoz
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TBD
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Neulasta
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November 18, 2015
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Complete response letter issued, June/July 2016; withdrew EMA application January 2017; new application possible 2019
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Pegfilgrastim
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Apotex
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TBD
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Neulasta
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December 17, 2014
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No FDA action reported (Complete response letter issued?)
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Pegfilgrastim
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Coherus Biosciences
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Udenyca™
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Neulasta
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August 9, 2016/May 3, 2018
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FDA Complete response letter issued June 12, 2017; New FDA decision expected by Nov 2, 2018
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Insulin Glargine*
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Merck/Samsung Bioepis
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Lusduna®
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Lantus
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August 5, 2016
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FDA approved July 20, 2017
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Trastuzumab
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Mylan/Biocon
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Ogivri® (trastuzumab-dkst)
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Herceptin
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November 1, 2016
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Approved December 3, 2017; not yet marketed
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Bevacizumab
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Amgen/Allergan
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Mvasi® (bevacizumab-awwb)
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Avastin
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November 15, 2016
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Approved September 14, 2017; not yet marketed
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Adalimumab
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Boehringer Ingelheim
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Cyltezo® (adalimumab-adbm)
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Humira
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January 18, 2017
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Approved August 29, 2017; not yet marketed
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Pegfilgrastim
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Mylan/Biocon
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Fulphila™ (pegfilgrastim-jmdb)
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Neulasta
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February 16, 2017
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FDA approved June 4, 2018; marketed
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Rituximab
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Teva/Celltrion
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Truxima
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Rituxan
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June 30, 2017/May 29, 2018
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FDA issued complete response letter April 5, 2018; Resubmitted 351(k) application May 29, 2018; FDA Advisory Committee voted 16-0 on October 10, 2018 to recommend approval
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Trastuzumab
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Pfizer
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TBD
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Herceptin
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Q3 2017
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FDA issued complete response letter April 23, 2018; nonclinical issues cited
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Trastuzumab
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Teva/Celltrion
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Herzuma
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Herceptin
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July 31, 2017/June 18, 2018
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FDA issued complete response letter April 5, 2018; Celltrion resubmitted BLA June 18, 2018
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Trastuzumab
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Amgen/Allergan
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TBD
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Herceptin
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July 31, 2017
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FDA issued complete response letter June 1, 2018
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Filgrastim
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Pfizer
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Nevistym™ (filgrastim-aafi)
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Neupogen
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Q4 2017
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FDA approved July 20, 2018; marketed
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Trastuzumab
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Samsung Bioepis
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TBD
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Herceptin
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December 20, 2017
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FDA decision expected Q4 2018
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Filgrastim
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Adello
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TBD
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Neupogen
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September 12, 2017
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FDA decision expected Q3 2018
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Rituximab
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Sandoz
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Rixathon
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Rituxan
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September 12, 2017
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FDA issued complete response letter May 2, 2018
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Adalimumab
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Sandoz
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TBD
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Humira
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January 16, 2018
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FDA decision expected Q4 2018
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Adalimumab
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Samsung Bioepis
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TBD
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Humira
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September 27, 2018
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FDA decision expected Q2-Q3 2019
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Filgrastim
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Tanvex Biologics
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TBD
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Neupogen
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October 1, 2018
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FDA decision expected Q3 2019
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*Product filed as follow-on biologic (351[a]), not as a biosimilar (351[k]).
Updated October 10, 2018.
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