Presented by Dr. Richard Dolinar, MD What is pharmacovigilance Track & Trace systems for biologic medicines Coding, Naming, Labeling Down the Road: Interchangeability and Drug Substitution
Presented by Dr. Richard Dolinar, MD What are biosimilars Why are biosimilars not generics Manufacturing The FDA’s “biosimilar pathway” Policy Considerations
Presented by Alliance Chairman, Dr. Richard Dolinar, MD Role of biotechnology in medical advancements What are biologics Examples of biologic medicines Manufacturing process Chemical drugs vs. biologic medicines Implications of size, variability, complexity What’s next for biotechnology