Biosimilars in Hematologic Oncology

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Presentation transcript:

Biosimilars in Hematologic Oncology

Brief History of Biosimilars

Biologics Manufacturing Process

Variabilities in Originator* Biologics and Biosimilars

Manufacturing Changes to Originator Biologics Across all Therapeutic Areas

Manufacturing Changes in Originator Biologic Rituximab

Changes to Biologics and Totality of Evidence

Regulatory Approval Process for Originator Biologics and Biosimilars

Differences Between Generics and Biosimilars

Regulatory Requirements for Changes in Manufacturing of Original Biologics and Biosimilar Development

Typical Quality Attributes to Be Evaluated in Similarity Assessment of a Monoclonal Antibody

Clinical Endpoints Supporting the Use of Biosimilars

Concerns Regarding Switching to Another Originator Drug or a Biosimilar: Immunogenicity

Oncologics Account for Highest Drug Class Spending in the United States

Ease of Access to Rituximab in Hem/Onc

The Impact of Biosimilar Filgrastim in Oncology

In Europe: The Vocabulary Distinguishes Replacement by Different Agents in the Process

Challenges in Switching to Biosimilars

Outcomes From Switching Studies

Clinical Data From Most Advanced Biosimilars in Hem/Onc: CT-P10 Study Design

Clinical Data From Most Advanced Biosimilars in Hem/Onc: CT-P10 PK Outcomes

Clinical Data From Most Advanced Biosimilars in Hem/Onc: CT-P10 Safety

Clinical Data From Most Advanced Biosimilars in Hem/Onc: GP-2013 Study Design

Clinical Data From Most Advanced Biosimilars in Hem/Onc: GP-2013 Efficacy Outcomes

Clinical Data From Most Advanced Biosimilars in Hem/Onc: GP-2013 Safety

Extrapolation of Indication

Conclusions

Abbreviations

Abbreviations (cont)

Abbreviations (cont)