Biosimilar Interchangeability & Substitution

Interchangeability remains a key milestone in biosimilar development, with significant clinical and policy implications. This session will explore scientific criteria, regulatory requirements, and global practices related to biosimilar interchangeability and automatic substitution. Topics include switching studies, pharmacovigilance requirements, prescriber perceptions, and legal frameworks across regions. Experts will share perspectives on building trust in biosimilars through transparency, education, and data-driven outcomes. Case studies will illustrate how real-world switching data supports or challenges substitution strategies in therapeutic areas such as rheumatology, oncology, and endocrinology. Participants will gain a deeper understanding of stakeholder roles in enabling successful biosimilar substitution, the economics of interchangeability, and the long-term impact on patient access and healthcare sustainability.

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