Table 2.
Biosimilars that have received marketing authorization in the EU.1
| Biosimilar name | Biosimilar active substance | Status (authorization or refusal date) | Manufacturer | Marketing authorization holder/applicant |
|---|---|---|---|---|
| Human erythropoietin products | ||||
| Abseamed | Epoetin alfa | Authorized (2007) | Rentschler Biotechnologie GmbH Lek Pharmaceuticals |
Medice Arzneimittel Pütter GmbH & Co. KG |
| Binocrit | Epoetin alfa | Authorized (2007) | Rentschler Biotechnologie GmbH Lek Pharmaceuticals |
Sandoz GmbH |
| Epoetin Alfa Hexal | Epoetin alfa | Authorized (2007) | Rentschler Biotechnologie GmbH Lek Pharmaceuticals |
Hexal AG |
| Retacrit | Epoetin zeta | Authorized (2007) | Norbitec GmbH | Hospira UK Ltd. |
| Silapo | Epoetin zeta | Authorized (2007) | Norbitec GmbH | Stada Arzneimittel AG |
| Human granulocyte colony-stimulating factor products | ||||
| Biograstim | Filgrastim | Authorized (2008) | SICOR Biotech UAB | CT Arzneimittel GmbH |
| Filgrastim Hexal | Filgrastim | Authorized (2009) | Sandoz GmbH | Hexal AG |
| Filgrastim ratiopharm | Filgrastim | Withdrawn2 (2008) | SICOR Biotech UAB | Ratiopharm GmbH |
| Grastofil | Filgrastim | Authorized (2013) | Intas Biopharmaceuticals Ltd. Apotex Nederland BV |
Apotex Europe BV |
| Nivestim | Filgrastim | Authorized (2010) | Hospira Zagreb | Hospira UK Ltd. |
| Ratiograstim | Filgrastim | Authorized (2008) | SICOR Biotech UAB | Ratiopharm GmbH |
| Tevagrastim | Filgrastim | Authorized (2008) | SICOR Biotech UAB | Teva Generics GmbH |
| Zarzio | Filgrastim | Authorized (2009) | Sandoz GmbH | Sandoz GmbH |
| Human growth hormone products | ||||
| Omnitrope | Somatropin | Authorized (2006) | Sandoz GmbH | Sandoz GmbH |
| Valtropin | Somatropin | Withdrawn3 (2006) | LG Life Sciences Ltd. | BioPartners GmbH |
| Human interferon α-2a product | ||||
| Alpheon | Recombinant human interferon α-2a | Refused (2006) | Rentschler Biotechnologie GmbH | BioPartners GmbH |
| Human follicle-stimulating hormone product | ||||
| Ovaleap | Follitropin alfa | Authorized (2013) | Merckle Biotec GmbH Teva Pharmaceuticals Europe BV |
Teva Pharma BV |
| Anti-human tumor necrosis factor α 2 monoclonal antibody | ||||
| Inflectra | Infliximab | Authorized (2013) | Celltrion Inc. | Hospira UK Ltd |
| Remsima | Infliximab | Authorized (2013) | Celltrion Inc. | Celltrion Healthcare Hungary Kft |
1
Information on clinical trials for these products is available in their respective assessment histories in the European Public Assessment Reports 12.
2
Marketing authorization in the EU withdrawn in 2011 at the request of the marketing authorization holder.
3
Marketing authorization in the EU withdrawn in 2012 at the request of the marketing authorization holder.