Table 1.
Summary of the ANVISA RDC 55/2010 requirements for each drug approval pathway.
| New biologic products |
Biologic products (follow on) |
||
|---|---|---|---|
| Comparability (biosimilar) |
Standalone (nonbiosimilar) |
||
| CMC documentation | Required | Comparative | According to standards* |
| Preclinical studies | Required | Comparative | Requirements may be reduced |
| Phase I and II clinical studies | Required | Comparative | Requirements can be waived and may not be comparative |
| Phase III clinical studies | Required | Comparative | Comparative with exceptions$ |
| Immunogenicity studies | Required | Required | Required |
| Same reference as comparator | NA | Yes | Not specified |
| Risk management plan | Required | Required | Required |
| Extrapolation of indications | NA | Possible | Not possible |
*
As per specifications of (Chemical manufacture and Control).
$
Blood derivatives, vaccines and oncological drugs.
ANVISA, National Health Surveillance Agency in Brazil; RDC, resolution of the board of directors; CMC, Chemical manufacture and Control; NA, not applicable.