Table II.
EMA-approved biosimilars in oncology.
| Biosimilar | Reference biologic (Active substance) | Manufacturer | Approval date |
|---|---|---|---|
| Alpheon | Roferon-A (recombinant human interferon-α-2α) | BioPartners GmbH | 05/09/2006 (Refused) |
| Abseamed | Eprex/Erypo (epoetin-α) | Medice Arzneimittel Putter GmbH & Co. Kg | 28/08/2007 |
| Binocrit | Eprex/Erypo (epoetin-α) | Sandoz GmbH | 28/08/2007 |
| Epoetin-α hexal | Eprex/Erypo (epoetin-α) | Hexal Ag | 28/08/2007 |
| Retacrit | Eprex/Erypo (epoetin-ζ) | Hospira UK Limited | 18/12/2007 |
| Silapo | Eprex/Erypo (epoetin-ζ) | Stada Arzneimittel Ag | 18/12/2007 |
| Ratiograstim | Neupogen (filgrastim) | Ratiopharm GmbH | 15/09/2008 |
| Tevagrastim | Neupogen (filgrastim) | Teva GmbH | 15/09/2008 |
| Biograstim | Neupogen (filgrastim) | Abz-Pharma GmbH | 15/09/2008 (withdrawn) |
| Filgrastim ratiopharm | Neupogen (filgrastim) | Ratiopharm GmbH | 15/09/2008 (withdrawn) |
| Zarzio | Neupogen (filgrastim) | Sandoz | 02/06/2009 |
| Filgrastim hexal | Neupogen (filgrastim) | Hexal Ag | 02/06/2009 |
| Nivestim | Neupogen (filgrastim) | Hospira UK | 08/06/2010 |
| Grastofil | Neupogen (filgrastim) | Apotex Europe Bv | 18/10/2013 |
| Accofil | Neupogen (filgrastim) | Accord Healthcare Ltd | 18/09/2014 |
| Truxima | MabThera (rituximab) | Celltrion Healthcare Hungary Kft. | 17/02/2017 |
| Riximyo | MabThera (rituximab) | Sandoz GmbH | 15/06/2017 |
| Rixathon | MabThera (rituximab) | Sandoz GmbH | 15/06/2017 |
| Rituzena | MabThera (rituximab) | Celltrion Healthcare Hungary Kft. | 13/07/2017 (approved) |
| (previously Tuxella) | 12/05/2019 (withdrawn) | ||
| Ritemvia | MabThera (rituximab) | Celltrion Healthcare Hungary Kft. | 13/07/2017 |
| Blitzima | MabThera (rituximab) | Celltrion Healthcare Hungary Kft. | 13/07/2017 |
| Ontruzant | Herceptin (trastuzumab) | Samsung Bioepis | 17/11/2017 |
| Mvasi | Avastin (bevacizumab) | Amgen Europe B.V. | 14/01/2018 |
| Herzuma | Herceptin (trastuzumab) | Celltrion Healthcare Hungary Kft. | 09/02/2018 |
| Kanjinti | Herceptin (trastuzumab) | Amgen Europe | 16/05/2018 |
| Trazimera | Herceptin (trastuzumab) | Pfizer Europe | 26/07/2018 |
| Pelgraz | Neulasta (pegfilgrastim) | Accord Healthcare Limited | 25/09/2018 |
| Udenyca | Neulasta (pegfilgrastim) | Coherus | 25/09/2018 |
| Fulphila | Neulasta (pegfilgrastim) | Mylan S.A.S. | 20/11/2018 |
| Pelmeg | Neulasta (pegfilgrastim) | Cinfa Biotech S.L. | 20/11/2018 |
| Ziextenzo | Neulasta (pegfilgrastim) | Sandoz GmbH | 22/11/2018 |
| Ogivri | Herceptin (trastuzumab) | Mylan S.A.S. | 12/12/2018 |
| Zirabev | Avastin (bevacizumab) | Pfizer Europe | 14/02/2019 |