US 351(k) Biosimilar Filings

BIOSIMILAR DRUG STATUS IN THE US: FDA FILING DATES AND ACTIONS

Biosimilar
Manufacturer
Brand Name & Designation
Innovator Product
FDA Filing Date
Status
Epoetin
Pfizer (Hospira)
Retacrit
Epogen
December 16, 2014
FDA Advisory Committee voted May 25, 2017 14-1 to recommend for approval; FDA issued 2nd complete response letter June 22, 2017
Filgrastim
Sandoz
Zarxio (filgrastim-sndz)
Neupogen
May 8, 2014
Approved March 6, 2015
Filgrastim
Apotex
TBD
Neupogen
February 13, 2015
No FDA Action
Infliximab
Celltrion/Pfizer
Inflectra (infliximab-dyyb)
Remicade
August 8, 2014
Approved April 5, 2016
Infliximab
Samsung Bioepis/Merck
Renflexis (infliximab-abda)
Remicade
May 23, 2016
Approved April 21, 2017
Etanercept
Sandoz
Erelzi (etanercept-szzs)
Enbrel
October 2, 2015
Approved August 31, 2016, all indications
Adalimumab
Amgen
Amjevita (adalimumab-atto)
Humira
November 25, 2015
Approved September 23, 2016, all indications
Pegfilgrastim
Sandoz
TBD
Neulasta
November 18, 2015
Complete response letter issued, June/July 2016; withdrew EMA application January 2017
Pegfilgrastim
Apotex
TBD
Neulasta
December 17, 2014
No FDA action (Complete response letter issued?)
Pegfilgrastim
Coherus Biosciences
TBD
Neulasta
August 9, 2016
FDA Complete response letter issued June 12, 2017
Insulin Glargine*
Merck/Samsung Bioepis
TBD
Lantus
August 5, 2016
FDA decision expected Q3, 2017
Trastuzumab
Mylan/Biocon
TBD
Herceptin
November 1, 2016
FDA Advisory Committee to review July 13, 2017; FDA decision expected by September 3, 2017
Bevacizumab
Amgen/Allergan
TBD
Avastin
November 15, 2016
FDA Advisory Committee to review July 13, 2017; FDA decision expected Q3, 2017
Adalimumab
Boehringer Ingelheim
TBD
Humira
January 18, 2017
FDA decision expected Q4, 2017
Pegfilgrastim
Mylan/Biocon
TBD
Neulasta
February 16, 2017
FDA decision expected Oct. 9, 2017
Rituximab
Celltrion
Truxima
Rituxan
NA
Celltrion announced planned filing by June 2017
Trastuzumab
Celltrion
Herzuma
Herceptin
NA
Celltrion announced planned filing by June 2017
*Product filed as follow-on biologic (351[a]), not as a biosimilar (351[k]).

Updated June 26, 2017