Classic generics | Biosimilars | |
---|---|---|
Manufacturing | Chemical synthesis | Genetically modified cell lines |
 | Simple microbial fermentation | Complex fermentation process |
 | Standard analytics | Complex purification process |
 |  | Formulation |
 |  | Complex analytical characterization |
Preclinic | Generally none | In vitro/in vivo bioassay |
 |  | Toxicity studies |
 |  | Local tolerance studies |
 |  | PK/PD studies |
Clinic | Generally BE study | Phase I PK/PD |
 |  | Phase III studies |
 |  | Phase IIIb studies |
 |  | Phase IV studes (PMS) |