Table 1.
Exclusivity expiration dates monoclonal antibodies in the European Union (EU) (GaBI, 2015; European Medicines Agency, 2015c).
| INN | Reference product | Exclusivity expiration EU | Biosimilar | Year of EMA approval |
|---|---|---|---|---|
| Infliximab | Remicade | 2015 | 1999 | |
| Inflectra | 2013 | |||
| Remsima | 2013 | |||
| Adalimumab | Humira | 2018 | / | 2003 |
| Etanercept* | Enbrel | 2015 | 2000 | |
| Benepali | 2016 | |||
| Rituximab | Rituxan | 2013 | / | 1998 |
| Trastuzumab | Herceptin | 2014 | / | 2000 |
| Bevacizumab | Avastin | 2022 | / | 2005 |
| Cetuximab | Erbitux | 2014 | / | 2004 |
| Ranibizumab | Lucentis | 2022 | / | 2007 |
*
Not a real mAb.