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Applying Biosimilars in Hematologic Cancers
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This program will include a discussion of off-label treatments and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal.
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There Is a Need to Reduce Costs, Improve Access to Biologics
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Biologics Are Complex
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Production of Biologics Is a Complicated Process
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Batch-to-Batch Variation Exists With All Biologics
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Regulation of Biosimilars
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Stepwise Process for Demonstrating Biosimilarity
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Development of Generic Drug vs New Biologic vs Biosimilar
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Biosimilar vs Interchangeable
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Extrapolation of Indications
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Hematology/Oncology Reference Products With Approved Biosimilar(s)
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Rituximab Biosimilars With Published Phase 3 Trials
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Implementing Biosimilars Into Practice: Experience in England
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Feasibility of Rapid Infusion of Biosimilar Rituximab
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Importance of Education and Communication
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Key Takeaways
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Abbreviations
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