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

Approved Pfizer’s resubmission (Nov 2017) on May 15, 2018

Filgrastim

Sandoz

Zarxio (filgrastim-sndz)

Neupogen

May 8, 2014

Approved March 6, 2015; marketed

Filgrastim

Apotex

TBD

Neupogen

February 13, 2015

No FDA Action

Infliximab

Celltrion/Pfizer

Inflectra (infliximab-dyyb)

Remicade

August 8, 2014

Approved April 5, 2016; marketed

Infliximab

Samsung Bioepis/Merck

Renflexis (infliximab-abda)

Remicade

May 23, 2016

Approved April 21, 2017; marketed

Infliximab

Pfizer

Ixifi (infliximab-qbtx)

Remicade

April 2017

Approved December 14, 2017, all indications; will not be marketed in US

Etanercept

Sandoz

Erelzi (etanercept-szzs)

Enbrel

October 2, 2015

Approved August 31, 2016, all indications; not yet marketed

Adalimumab

Amgen

Amjevita (adalimumab-atto)

Humira

November 25, 2015

Approved September 23, 2016, all indications; not yet marketed

Pegfilgrastim

Sandoz

TBD

Neulasta

November 18, 2015

Complete response letter issued, June/July 2016; withdrew EMA application January 2017; new application possible 2019

Pegfilgrastim

Apotex

TBD

Neulasta

December 17, 2014

No FDA action (Complete response letter issued?)

Pegfilgrastim

Coherus Biosciences

TBD

Neulasta

August 9, 2016/May 3, 2018

FDA Complete response letter issued June 12, 2017; Refiled 351(k) application May 3, 2018

Insulin Glargine*

Merck/Samsung Bioepis

Lusduna™

Lantus

August 5, 2016

FDA approved July 20, 2017

Trastuzumab

Mylan/Biocon

Ogivri™ (trastuzumab-dkst)

Herceptin

November 1, 2016

Approved December 3, 2017; not yet marketed

Bevacizumab

Amgen/Allergan

Mvasi™ (bevacizumab-awwb)

Avastin

November 15, 2016

Approved September 14, 2017; not yet marketed

Adalimumab

Boehringer Ingelheim

Cyltezo™ (adalimumab-adbm) 

Humira

January 18, 2017

Approved August 29, 2017; not yet marketed

Pegfilgrastim

Mylan/Biocon

Fulphila™ (pegfilgrastim-jmdb)

Neulasta

February 16, 2017

FDA approved June 2, 2018

Rituximab

Teva/Celltrion

Truxima

Rituxan

June 30, 2017

FDA issued complete response letter April 5, 2018; Celltrion resubmitted  BLA May 29, 2018

Trastuzumab

Pfizer

TBD

Herceptin

Q3 2017

FDA issued complete response letter April 23, 2018; nonclinical issues cited

Trastuzumab

Teva/Celltrion

Herzuma

Herceptin

July 31, 2017

FDA issued complete response letter April 5, 2018; manufacturing plant issues; Celltrion resubmitted BLA June 18, 2018

Trastuzumab

Amgen/Allergan

TBD

Herceptin

July 31, 2017

FDA issued complete response letter June 1, 2018

Trastuzumab

Samsung Bioepis

TBD

Herceptin

December 20, 2017

FDA decision expected Q4 2018

Filgrastim

Adello

TBD

Neupogen

September 12, 2017

FDA decision expected Q3 2018

Rituximab

Sandoz

TBD

Rituxan

September 12, 2017

FDA issued complete response letter May 2, 2018

Adalimumab

Sandoz

TBD

Humira

January 16, 2018

FDA decision expected Q4 2018

*Product filed as follow-on biologic (351[a]), not as a biosimilar (351[k]).

Updated June 18, 2018