How To Avoid A Biosimilar Comparative Efficacy Study, If Possible

Few companies, if any, would ever eagerly volunteer to perform a comparative efficacy study (CES) for their biosimilar candidate. The FDA has been clear all along that compelling a CES remains a tool in its toolbox if the agency believes it's necessary. So what might trigger one, and how can companies avoid it?

During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, Cecilia Michel, managing director and head of research and development strategy at Alvotech, said the comparative analytical assessment (CAA) is key. The analytical package should include at a minimum orthogonal assays, both physical/chemical, potency, and binding, among others, to truly understand your molecule and its mechanism of action.

Early and ongoing engagement with the FDA is also important.