BIOSIMILARS APPROVED AND FILED 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
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Epogen
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December 16, 2014
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FDA Advisory Committee voted May 25, 2017 14-1 to recommend for approval; FDA issued 2nd complete response letter June 22, 2017; resubmitted to FDA November 2017
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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
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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 (Complete response letter issued?)
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Pegfilgrastim
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Coherus Biosciences
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TBD
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Neulasta
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August 9, 2016
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FDA Complete response letter issued June 12, 2017
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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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TBD
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Neulasta
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February 16, 2017
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FDA issued complete response letter Oct. 10, 2017; FDA reevaluation expected by June 2018
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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
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FDA issued complete response letter April 5, 2018; manufacturing plant issues
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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
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FDA issued complete response letter April 5, 2018; manufacturing plant issues
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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 decision expected Q2 2018
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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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TBD
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Rituxan
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September 12, 2017
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FDA decision expected Q3 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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*Product filed as follow-on biologic (351[a]), not as a biosimilar (351[k]).
Updated April 13, 2018
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