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Session 7: Flipping the Switch: Building Confidence About Biosimilar Transitions and Substitutions
Session Chair(s)
Stacey Ricci, DRSC
Director, Scientific Review Staff, OTBB, CDER, FDA, United States
Increasing the availability of biosimilars is an important public health strategy for reducing drug costs and increasing the availability of biologics to underserved populations. However, misperceptions exist regarding the safety of switching to a biosimilar product as does confusion regarding substitution and interchangeability. This session will provide a global perspective on the scientific and regulatory landscape of biosimilar switching and substitution as well as an overview of safety data from the US perspective. An overview of current barriers to understanding from the patient and caregiver perspective plus ongoing efforts to increase awareness and education will be provided.
Learning Objective : - Identify and compare policies on an international level about biosimilar uptake, switching and substitution
- Assess safety and immunogenicity outcomes in patients participating in controlled clinical studies and observational studies that evaluated one or more transitions between biosimilar and reference products
- Evaluate the impact of misinformation, market forces and the managed care landscape in the context of switching and pharmacy-level substitution
Speaker(s)
Julie Marechal-Jamil, MSC
Director, Biosimilar Policy and Science, Medicines For Europe, Belgium
Speaker
Thomas Herndon, MD
Senior Scientific Reviewer, Office of Therapeutic Biologics and Biosimilars, FDA, United States
Speaker
Sonia Tadjalli Oskouei, PHARMD
Vice President & US Head, Biosimilars and Specialty, Sandoz, United States
Speaker
Anna Hyde, MA
Vice President of Advocacy & Access, Arthritis Foundation, United States
Speaker
Ms. Sarah Ikenberry
Associate Director, Stakeholder Engagement and Education, OTBB, CDER, US FDA, United States
Speaker
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