Applying Biosimilars in Oncology Practice: What Do You Need to Know?

Introduction

What Is a Biosimilar?

How Do Biosimilars Compare With Small Molecules Generics?

Biosimilars Have Increased in Size and Complexity

Biosimilar Guidance: EMA 2017

The Principles of Biosimilar Development as Detailed in Guidelines Is Based on the Totality of Evidence

The Stepwise Approach to Establish the Totality of Evidence

Equivalence Studies Are Necessary to Demonstrate Biosimilarity

Monoclonal Antibodies Have Many Quality Attributes That Must Be Characterized With Analytical Methods

Cost Considerations

Pharmacovigilance

Definitions of Substitution, Switching, and Interchangeability

Recommendations for Switching and Substitution of Biosimilars

Conclusions

Abbreviations