Understanding Biologics

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Presentation transcript:

Understanding Biologics

Biologics and Biosimilars

Animation: What Are Biologics?

Production of Biologics

Sources of Variation in Biologics

Variability Is a Natural and Expected Property of All Biologics

Glycosylation Affects Protein Properties

Most Biologics Have Undergone Manufacturing Changes

Trastuzumab Properties Over Time

Different Batches of Biologics Are Similar but Not Identical

Similarity Assessment of a Monoclonal Antibody: Typical Attributes to Evaluate

The EMA Uses a Comparability Exercise to Evaluate Manufacturing Changes to Approved Biologics

Comparability Exercise Allows Different Product Originator Batches in the Market

Analytical Methods to Ensure Batch-to-Batch Consistency

Changes in Rituximab Properties Across Batches

Originator and Biosimilar Development

Approval of Biologic Manufacturing Changes vs Approval of a Biosimilar

Clinical Trial Designs Used to Evaluate Biosimilars

Clinical Trials Evaluating the Rituximab Biosimilar GP2013

Immunogenicity Varies Among Biologics

Role of Pharmacovigilance

Switching Patients From Originator to Biosimilar

Concluding Remarks

Abbreviations

Abbreviations (cont)