Biosimilars
ICON’s immunoassay team has extensive expertise in the development and validation of PK and ADA assays to support Biosimilar programs including Rituximab, Infliximab, Trastuzumab, Etanercept, Bevacizumab, Cetuximab, Filgrastim, Pegfilgrastim, Estradiol and Peg-interferon alfa 2a.
We’re actively expanding our validated assay list to enable sponsors to expedite and streamline the development of their Biosimilar compound. The methodology used in the development of these assays is directly in line with the recent FDA guidance issued as well as EMEA guidance, and the latest additions include:
| Rituximab | PK/ADA Available |
| Trastuzumab | PK/ADA Available |
| Etanercept | PK/ADA Available |
| PEGASYS | PK Available |
| Infliximab | PK Available |
| Adalimumab | Available Q2 2013 |
| Bevacizumab | Available Q1 2013 |
