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Applying Biosimilars in Hematologic Cancers

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Presentation on theme: "Applying Biosimilars in Hematologic Cancers"— Presentation transcript:

1 Applying Biosimilars in Hematologic Cancers

2

3 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.

4 There Is a Need to Reduce Costs, Improve Access to Biologics

5 Biologics Are Complex

6 Production of Biologics Is a Complicated Process

7 Batch-to-Batch Variation Exists With All Biologics

8 Regulation of Biosimilars

9 Stepwise Process for Demonstrating Biosimilarity

10 Development of Generic Drug vs New Biologic vs Biosimilar

11 Biosimilar vs Interchangeable

12 Extrapolation of Indications

13 Hematology/Oncology Reference Products With Approved Biosimilar(s)

14 Rituximab Biosimilars With Published Phase 3 Trials

15 Implementing Biosimilars Into Practice: Experience in England

16 Feasibility of Rapid Infusion of Biosimilar Rituximab

17 Importance of Education and Communication

18 Key Takeaways

19 Abbreviations


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