The science of biosimilars continues to evolve, and development programs must keep pace if candidate products are to meet changing standards at the time of evaluation. Approval of a biosimilar is just the beginning of the post-market challenges that await, including life cycle management, but most importantly, ensuring that prescribers and patients are aware of the value of the biosimilar as a safe and effective therapy. 

DIA's Biosimilars Conference gives you access to the knowledge you need to bring your effective biosimilar to market and position it as a therapy of choice to meet patient needs:

• State of the science analytical tools and biological assays in the evaluation of molecular similarities and differences and the assessment of significance of differences
• Ask the Regulators: Dedicated question and answer session on regional-specific and global alignment issues with regulators from the EU, FDA, Health Canada, PMDA, and the World Health Organization
• Direct discussion with patients, prescribers, and payers on how these stakeholders perceive the value of biosimilars
• Focus on the postmarket phase of biosimilars, from fundamental life cycle management issues and differences from original biologics to changes needed to meet the opportunity for interchangeability

Featured Topics

• State of the science analytic techniques and biological assays to identify and quantify molecular similarities and differences
• Quantitative approaches for evaluation of similarity data
• Enhancements under BsUFA II to facilitate first-cycle approvals of biosimilar applications
• US FDA final guidance on Interchangeability, and industry perspective on demonstrating interchangeability
• Perspectives of patients, payers, and prescribers and how to address these stakeholders needs around biosimilars
• Recent and coming policy and regulatory developments for biosimilars in the EU, Japan, Canada, and other significant international regions
• Global information exchange and multi-lateral collaboration platforms for biosimilars and how their results affect your development program
• Postmarket life cycle management of biosimilars and differences from original biologics: manufacturing changes, labeling maintenance, PREA requirements, opportunities for interchangeability 
• Considerations for new indications, additional dosage forms, and presentations
• Concepts and legal and regulatory frameworks for interchangeability in the EU and US
• Combination product considerations (see also: Combination Products Conference)

On-Demand Complimentary Webinar