FDA regulatory process for biologics versus biosimilars approval [3]
| Process | Biologic | Biosimilar |
|---|---|---|
| Quality factors | Characterization of product (target selection, molecular design, etc.) | Characterization of product (target selection, molecular design, etc.); comparison to the original biologic |
| Preclinical | In vivo and in vitro study demonstrating pharmacodynamics, toxicity, and immunogenicity profile | In vivo and in vitro study demonstrating similarity of pharmacodynamics, toxicity, and immunogenicity profile compared to the original biologic |
| Clinical | Phase I clinical trials | Phase I clinical trials |
| Phase II clinical trials | Phase II clinical trials are not required | |
| Phase III clinical trials with a large sample size, for all indications | Initially, the FDA did require a switching arm against the reference product. In interchangeability trials, multiple switches were required, too. Phase III clinical trials are no longer an absolute requirement for approval |
FDA: Food and Drug Administration