Table 4 Biosimilar products that had gained marketing authorization within the European Union and/or the United States by July 2018
Product type | Biosimilar (trade name) | Year (and region) approved | Reference product | Drug (active ingredient) manufacturer |
|---|---|---|---|---|
Somatropin-based | ||||
Human growth hormone–based | Omnitrope | 2006 (EU) | Genotropin | Sandoz (Kundl, Austria) |
| Â | Valtropin | 2006 (EU) Withdrawn 2012 | Humatrope | LG Life Sciences (Jeonbuk-do, Republic of Korea) |
Epoetin-based | ||||
Epoetin-based | Binocrit | 2007 (EU) | Eprex/Erypo | Rentschler (Laupheim, Germany) & Lek (Menges, Slovenia) |
| Â | Epoetin alfa hexal | 2007 (EU) | Eprex/Erypo | Rentschler & Lek |
| Â | Abseamed | 2007 (EU) | Eprex/Erypo | Rentschler & Lek |
| Â | Retacrit | 2018 (US) 2007 (EU) | Eprex/Erypo (EU) Epogen/Procrit (US) | Norbitec (Uetersen, Germany) Norbitec (Uetersen, Germany) |
| Â | Silapo | 2007 (EU) | Eprex/Erypo | Norbitec |
Filgrastim-based | ||||
G-CSF-based | Ratiograstim | 2008 (EU) | Neupogen | Sicor (Vilnius, Lithuania) |
| Â | Filgrastim ratiopharm | 2008 (EU) Withdrawn 2011 | Neupogen | Sicor |
| Â | Biograstim | 2008 (EU) Withdrawn 2015 | Neupogen | Sicor |
| Â | Tevagrastim | 2008 (EU) | Neupogen | Sicor |
| Â | Zarxio (US) Zarzio (EU) | 2015 (US) 2009 (EU) | Neupogen | Sandoz (Kundl, Austria) |
| Â | Filgrastim hexal | 2009 (EU) | Neupogen | Sandoz (Kundl, Austria) |
| Â | Nivestym (US) Nivestim (EU) | 2018 (US) 2010 (EU) | Neupogen | Hospira (Pfizer) (Zagreb, Croatia) |
| Â | Grastofil | 2013 (EU) | Neupogen | Intas Biopharmaceuticals (Gujarat, India) |
| Â | Accofil | 2014 (EU) | Neupogen | Intas Biopharmaceuticals |
Pegfilgrastim-based | Fulphila | 2018 (US) | Neulasta | Mylan (Zurich) |
Follicle-stimulating hormone–based | ||||
Follicle-stimulating hormone–based | Ovaleap | 2013 (EU) | Gonal F | Merckle Biotec (Ulm, Germany) |
| Â | Bemfola | 2014 (EU) | Gonal F | Polymun Scientific Immunbiologische Forschung (Klosterneuburg, Austria) |
Insulin-based | ||||
Insulin glargine–based | Abasaglar | 2014 (EU) | Lantus | Lilly del Caribe (Carolina, Puerto Rico, USA) Eli Lilly (Indianapolis) |
| Â | Lusduna | 2017 (EU) 2017 (US), tentative | Lantus | Merck Sharp & Dohme (Elkton, VA, USA) |
| Â | Semglee | 2018 (EU) | Lantus | Biocon Nusajaya (Johor, Malaysia) |
Insulin lispro–based | Insulin lispro Sanofi | 2017 (EU) | Humalog | Sanofi-Aventis (Frankfurt) |
mAb-based and related | ||||
Infliximab-based | Inflectra | 2016 (US) 2013 (EU) | Remicade | Celltrion (Incheon, Republic of Korea) |
| Â | Remsima | 2013 (EU) | Remicade | Celltrion |
| Â | Flixabi | 2016 (EU) | Remicade | Biogen (Hillerod, Denmark) Samsung Bioepis (Incheon, Republic of Korea) |
| Â | Renflexis | 2017 (US) | Remicade | Biogen (Hillerod, Denmark) Samsung Bioepis |
| Â | Ixifi | 2017 (US) | Remicade | Pfizer |
| Â | Zessly | 2018 (EU) | Remicade | Boehringer Ingelheim (Biberach an der Riss, Germany) |
Adalimumab-based | Amgevita (EU)Amjevita (US) | 2017 (EU) 2016 (US) | Humira | Amgen (Thousand Oaks, CA, USA) |
| Â | Solymbic | 2017 (EU) | Humira | Amgen |
| Â | Cyltezo | 2017 (EU & US) | Humira | Boehringer Ingelheim (Fremont, CA, USA) |
| Â | Halimatoz | 2018 (EU) | Humira | Cook Pharmica (Bloomington IN, USA) Sandoz (Langkampfen, Austria) |
| Â | Hefiya | 2018 (EU) | Humira | Cook Pharmica (Bloomington IN, USA) Sandoz (Langkampfen, Austria) |
| Â | Hyrimoz | 2018 (EU) | Humira | Cook Pharmica (Bloomington IN, USA) Sandoz (Langkampfen, Austria) |
|  | Imraldi | 2017 (EU) | Humira | Biogen (Research Triangle Park, NC, USA) Biogen (Hillerød, Denmark) |
Rituximab-based | Blitzima | 2017 (EU) | MabThera | Celltrion |
| Â | Truxima | 2017 (EU) | MabThera | Celltrion |
| Â | Ritemvia | 2017 (EU) | MabThera | Celltrion |
| Â | Rituzena | 2017 (EU) | MabThera | Celltrion |
| Â | Rixathon | 2017 (EU) | MabThera | Sandoz (Langkampfen, Austria) |
| Â | Riximyo | 2017 (EU) | MabThera | Sandoz (Langkampfen, Austria) |
Trastuzumab-based | Ontruzant | 2017 (EU) | Herceptin | Biogen (Hillerød, Denmark) |
| Â | Ogivri | 2017 (US) | Herceptin | Mylan |
| Â | Herzuma | 2018 (EU) | Herceptin | Celltrion |
| Â | Kanjinti | 2018 (EU) | Herceptin | Patheon Biologics (Groningen, the Netherlands) |
| Â | Trazimera | 2018 (EU) | Herceptin | Boehringer Ingelheim (Biberach an der Riss, Germany) |
Bevacizumab-based | Mvasi | 2018 (EU) 2017 (US) | Avastin | Amgen |
Etanercept-based | Benepali | 2016 (EU) | Enbrel | Biogen (Hillerød, Denmark) |
| Â | Erelzi | 2017 (EU) 2016 (US) | Enbrel | Sandoz (Novartis) (Langkampfen, Austria) (EU) Novartis Pharma (Stein, Switzerland) (US) |
Teriparatide-based | ||||
Teriparatide-based | Movymia | 2017 (EU) | Forsteo | Richter-Helm BioLogics (Bovenau, Germany) |
| Â | Terrosa | 2017 (EU) | Forsteo | Richter-Helm BioLogics |
