FDA: Biosimilars Resource Center
FDA: Purple Book Database of Licensed Biological Products
European Medicines Agency: Biosimilar Medicines Resource Center
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Thursday, June 1, 2023
This project is supported by funding from the US Food & Drug Administration.
Biologics are therapies for managing immunologic and inflammatory disorders, cancer, and other conditions. However, patient
access to biologic therapies has remained limited. Biosimilars and interchangeable products have the potential to increase
access for patients and potentially lower treatment costs. Limited understanding of healthcare providers and patients and
concerns about clinical performance of biosimilars and interchangeable products compared with the reference product have limited
clinical use, despite biosimilars and interchangeable products being highly similar and producing the same clinical result
with no clinically meaningful differences.
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