• Global Regulatory Updates
• Totality of the Evidence
• Clinical Relevance of Critical Quality Attributes (CQA)
• Challenges of Generating Clinical Data
• Real-World Evidence: Post-Approval
• Interchangeability and Switching
• Education
• Patient Access

• Pharmaceutical Executives
• Biomedical Product Developers
• Regulatory Affairs Professionals
• Clinical and Nonclinical Researchers
• Biostatisticians and Data Managers
• Business Development Executives
• Marketing and Commercialization Staff involved with Biosimilars

At the conclusion of this conference, participants should be able to:

• Describe how the totality of evidence, including CMC, in vitro, nonclinical, and clinical data, can be amalgamated to demonstrate biosimilarity and meet regulatory expectations for approval of biosimilar applications
• Discuss the concept of the clinical relevance of critical quality attributes and the assessment of their impact on potency, PK, immunogenicity, and safety 
• Explain the extent to which critical quality attributes need to align with the reference product and the application of statistical approaches that will meet regulatory requirements for acceptance of biosimilarity
• Discuss the challenges in generating the requisite clinical data to confirm biosimilarity and considerations for designing a successful biosimilar clinical trials program to meet global requirements
• Examine the impact of  adoption of biosimilars and (potentially) interchangeable biologics by prescribers and health care professionals on their introduction to patients
• Outline the need and potential approaches for education on the concept and value of biosimilars