TABLE 1.
List of Biosimilar Products Approved by the EMA18
| Nonproprietary Name Substance | Medicine Name | Marketing Authorization Holder | Year of Approval | Reference Product (Innovator) |
|---|---|---|---|---|
| Epoetin alfa | Abseamed | MEDICE Arzneimittel Pütter GmbH & Co. KG | 2007 | Eprex/Erypo (Janssen-Cilag GmbH) |
| Epoetin alfa | Binocrit | Sandoz GmbH | 2007 | |
| Epoetin alfa | Epoetin Alfa Hexal | Hexal AG | 2007 | |
| Epoetin zeta | Retacrit | Hospira UK Limited | 2007 | |
| Epoetin zeta | Silapo | STADA Arzneimittel AG | 2007 | |
| Filgrastim | Accofil | Accord Healthcare Ltd | 2014 | Neupogen (Amgen) |
| Filgrastim | Biograstim | AbZ-Pharma GmbH | 2008 | |
| Filgrastim | Filgrastim Hexal | Hexal AG | 2009 | |
| Filgrastim | Filgrastim ratiopharma | Ratiopharm GmbH | 2008 | |
| Filgrastim | Grastofil | Apotex Europe BV | 2013 | |
| Filgrastim | Nivestim | Hospira UK Ltd. | 2010 | |
| Filgrastim | Ratiograstim | Ratiopharm GmbH | 2008 | |
| Filgrastim | Tevagrastim | Teva GmbH | 2008 | |
| Filgrastim | Zarzio | Sandoz GmbH | 2009 | |
| Follitropin alfa | Bemfola | Finox Biotech AG | 2014 | Gonal-F (Merck Serono Europe Ltd) |
| Follitropin alfa | Ovaleap | Teva Pharma BV | 2013 | |
| Infliximab | Inflectra | Hospira UK Limited | 2013 | Remicade (Janssen Biologics BV) |
| Iinfliximab | Remsima | Celltrion Healthcare Hungary Kft. | 2013 | |
| Insulin glargine | Abasria | Eli Lilly Regional Operations GmbH | 2014 | Lantus (Sanofi) |
| Somatropin | Omnitrope | Sandoz GmbH | 2006 | Genotropin (Pfizer) |
| Somatropin | Valtropina | Biopartners GmbH | 2006 | Humatrope (Eli Lilly) |
a Withdrawn after approval.
EMA = European Medicine Agency.