The Burden Of Proof Has Shifted To Analytics For Biosimilar Approval

The FDA's recent and stunning declaration that comparative analytical assessments (CAA) are generally more sensitive than clinical efficacy studies (CES) shows the great degree in which the agency is leaning on analytics rather than clinical data when considering 351(k) applications for biosimilars.

During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, Diana Colleluori, a principal consultant at Biologics Consulting Group, explained that it shows FDA is learning along with the rest of us that CES is not the definitive biosimilarity indicator we thought it was.