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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, OND, 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)
Speaker
Julie Marechal-Jamil, MSc
Medicines For Europe, Belgium
Director, Biosimilar Policy and Science
Speaker
Thomas Herndon, MD
FDA, United States
Senior Scientific Reviewer, Office of Therapeutic Biologics and Biosimilars
Speaker
Sonia Tadjalli Oskouei, PharmD
Sandoz, United States
Vice President & US Head, Biosimilars and Specialty
Speaker
Anna Hyde, MA
Arthritis Foundation, United States
Vice President of Advocacy & Access
Speaker
Sarah Crowley-Ikenberry, MA
FDA, United States
Senior Communication Advisor, OTBB, OND, CDER
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