Process Control's Increasing Role In Biosimilar Approval

Regulators are moving away from comparative efficacy studies in biosimilar approval, shifting the burden of generating proof of biosimilarity onto analytical departments. Our panel, including Diana Colleluori, Ph.D., and Vince Narbut, Ph.D., of Biologics Consulting Group and Cecilia Michel, Ph.D., of Alvotech, explored what the changes mean for process development and analytical teams.