Biosimilars Approval Process

Summary

Analysis. Development. Testing. Hear from Carlos Sattler, VP of Clinical Development & Medical Affairs; Julia Pike, SVP of Intellectual Property; Cindy Cao, ... Markus Hartmann, PhD, from European Consulting & Contracting in Oncology, Trier, Germany, discusses the This video provides a high-level overview of the regulatory ASBM's inaugural Chair, Richard Dolinar MD; and his successors Immediate Past Chair Harry Gewanter MD MACR; and ASBM's ... The structure of biological products is typically more complex than small molecule drugs. As a result, In the totality-of-the-evidence approach, FDA considers all the available evidence needed to make a regulatory decision about a ...