Table 4 Biosimilar products that had gained marketing authorization within the European Union and/or the United States by July 2018

From: Biopharmaceutical benchmarks 2018

Product typeBiosimilar (trade name)Year (and region) approvedReference productDrug (active ingredient) manufacturer
Somatropin-based
Human growth hormone–basedOmnitrope2006 (EU)GenotropinSandoz (Kundl, Austria)
 Valtropin2006 (EU)
Withdrawn 2012
HumatropeLG Life Sciences (Jeonbuk-do, Republic of Korea)
Epoetin-based
Epoetin-basedBinocrit2007 (EU)Eprex/ErypoRentschler (Laupheim, Germany) & Lek (Menges, Slovenia)
 Epoetin alfa hexal2007 (EU)Eprex/ErypoRentschler & Lek
 Abseamed2007 (EU)Eprex/ErypoRentschler & Lek
 Retacrit2018 (US)
2007 (EU)
Eprex/Erypo (EU)
Epogen/Procrit (US)
Norbitec (Uetersen, Germany)
Norbitec (Uetersen, Germany)
 Silapo2007 (EU)Eprex/ErypoNorbitec
Filgrastim-based
G-CSF-basedRatiograstim2008 (EU)NeupogenSicor (Vilnius, Lithuania)
 Filgrastim ratiopharm2008 (EU)
Withdrawn 2011
NeupogenSicor
 Biograstim2008 (EU)
Withdrawn 2015
NeupogenSicor
 Tevagrastim2008 (EU)NeupogenSicor
 Zarxio (US)
Zarzio (EU)
2015 (US)
2009 (EU)
NeupogenSandoz (Kundl, Austria)
 Filgrastim hexal2009 (EU)NeupogenSandoz (Kundl, Austria)
 Nivestym (US)
Nivestim (EU)
2018 (US)
2010 (EU)
NeupogenHospira (Pfizer) (Zagreb, Croatia)
 Grastofil2013 (EU)NeupogenIntas Biopharmaceuticals (Gujarat, India)
 Accofil2014 (EU)NeupogenIntas Biopharmaceuticals
Pegfilgrastim-basedFulphila2018 (US)NeulastaMylan (Zurich)
Follicle-stimulating hormone–based
Follicle-stimulating hormone–basedOvaleap2013 (EU)Gonal FMerckle Biotec (Ulm, Germany)
 Bemfola2014 (EU)Gonal FPolymun Scientific Immunbiologische Forschung (Klosterneuburg, Austria)
Insulin-based
Insulin glargine–basedAbasaglar2014 (EU)LantusLilly del Caribe (Carolina, Puerto Rico, USA)
Eli Lilly (Indianapolis)
 Lusduna2017 (EU)
2017 (US), tentative
LantusMerck Sharp & Dohme (Elkton, VA, USA)
 Semglee2018 (EU)LantusBiocon Nusajaya (Johor, Malaysia)
Insulin lispro–basedInsulin lispro Sanofi2017 (EU)HumalogSanofi-Aventis (Frankfurt)
mAb-based and related
Infliximab-basedInflectra2016 (US)
2013 (EU)
RemicadeCelltrion (Incheon, Republic of Korea)
 Remsima2013 (EU)RemicadeCelltrion
 Flixabi2016 (EU)RemicadeBiogen (Hillerod, Denmark)
Samsung Bioepis (Incheon, Republic of Korea)
 Renflexis2017 (US)RemicadeBiogen (Hillerod, Denmark)
Samsung Bioepis
 Ixifi2017 (US)RemicadePfizer
 Zessly2018 (EU)RemicadeBoehringer Ingelheim (Biberach an der Riss, Germany)
Adalimumab-basedAmgevita (EU)Amjevita (US)2017 (EU)
2016 (US)
HumiraAmgen (Thousand Oaks, CA, USA)
 Solymbic2017 (EU)HumiraAmgen
 Cyltezo2017 (EU & US)HumiraBoehringer Ingelheim (Fremont, CA, USA)
 Halimatoz2018 (EU)HumiraCook Pharmica (Bloomington IN, USA)
Sandoz (Langkampfen, Austria)
 Hefiya2018 (EU)HumiraCook Pharmica (Bloomington IN, USA)
Sandoz (Langkampfen, Austria)
 Hyrimoz2018 (EU)HumiraCook Pharmica (Bloomington IN, USA)
Sandoz (Langkampfen, Austria)
 Imraldi2017 (EU)HumiraBiogen (Research Triangle Park, NC, USA)
Biogen (Hillerød, Denmark)
Rituximab-basedBlitzima2017 (EU)MabTheraCelltrion
 Truxima2017 (EU)MabTheraCelltrion
 Ritemvia2017 (EU)MabTheraCelltrion
 Rituzena2017 (EU)MabTheraCelltrion
 Rixathon2017 (EU)MabTheraSandoz (Langkampfen, Austria)
 Riximyo2017 (EU)MabTheraSandoz (Langkampfen, Austria)
Trastuzumab-basedOntruzant2017 (EU)HerceptinBiogen (Hillerød, Denmark)
 Ogivri2017 (US)HerceptinMylan
 Herzuma2018 (EU)HerceptinCelltrion
 Kanjinti2018 (EU)HerceptinPatheon Biologics (Groningen, the Netherlands)
 Trazimera2018 (EU)HerceptinBoehringer Ingelheim (Biberach an der Riss, Germany)
Bevacizumab-basedMvasi2018 (EU)
2017 (US)
AvastinAmgen
Etanercept-basedBenepali2016 (EU)EnbrelBiogen (Hillerød, Denmark)
 Erelzi2017 (EU)
2016 (US)
EnbrelSandoz (Novartis) (Langkampfen, Austria) (EU)
Novartis Pharma (Stein, Switzerland) (US)
Teriparatide-based
Teriparatide-basedMovymia2017 (EU)ForsteoRichter-Helm BioLogics (Bovenau, Germany)
 Terrosa2017 (EU)ForsteoRichter-Helm BioLogics