Adapting to a changing and dynamic regulatory landscape is paramount for success in the biosimilars and innovator biologics markets. In this comprehensive session, industry leaders will demonstrate how proactive adaptation and strategic foresight are essential for a competitive advantage. Topics of discussion include:

• Crafting successful BLAs
• Reviewing FDA’s draft guidance on diversity in clinical trials
• Proactively evaluating manufacturing for compliance with applicable laws and regulations towards passing the FDA’s pre-approval inspection
• Strategies for effective manufacturing monitoring and compliance outside of the U.S.
• Navigating the FDA’s attempts to streamline data requirements for biosimilarily and interchangeable status
• Identifying the data required by FDA to approve biosimilars for use in specific indications or populations without direct clinical trials
• Considering the role switching studies currently play in the approval process and evaluating their necessity
• Evaluating the impact that interchangeable status has on market uptake
• Comparing conflicting state laws on interchangeability
• Unpacking the updated FDA labelling recommendations
• Understanding when information can put you at risk for infringement claims regardless of labeling revisions have been approved by FDA as part of a skinny label
• Analyzing the evolving jurisprudence for induced infringement of follow-on biologics