This program will include a discussion of offlabel 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 peerreviewed journal ID: 736325
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Applying Biosimilars in Hematologic CancersSlide2Slide3
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.Slide4
There Is a Need to Reduce Costs, Improve Access to BiologicsSlide5
Biologics Are ComplexSlide6
Production of Biologics Is a Complicated ProcessSlide7
Batch-to-Batch Variation Exists With All BiologicsSlide8
Regulation of BiosimilarsSlide9
Stepwise Process for Demonstrating BiosimilaritySlide10
Development of Generic Drug vs New Biologic vs BiosimilarSlide11
Biosimilar vs InterchangeableSlide12
Extrapolation of IndicationsSlide13
Hematology/Oncology Reference Products With Approved Biosimilar(s)Slide14
Rituximab Biosimilars With Published Phase 3 TrialsSlide15
Implementing Biosimilars Into Practice:Experience in EnglandSlide16
Feasibility of Rapid Infusion of Biosimilar RituximabSlide17
Importance of Education and CommunicationSlide18
Key TakeawaysSlide19
Abbreviations