Applying Biosimilars in Hematologic Cancers

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.

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

Biologics Are Complex

Production of Biologics Is a Complicated Process

Batch-to-Batch Variation Exists With All Biologics

Regulation of Biosimilars

Stepwise Process for Demonstrating Biosimilarity

Development of Generic Drug vs New Biologic vs Biosimilar

Biosimilar vs Interchangeable

Extrapolation of Indications

Hematology/Oncology Reference Products With Approved Biosimilar(s)

Rituximab Biosimilars With Published Phase 3 Trials

Implementing Biosimilars Into Practice: Experience in England

Feasibility of Rapid Infusion of Biosimilar Rituximab

Importance of Education and Communication

Key Takeaways

Abbreviations