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DIA Biosimilars Conference 2017 Posted 08/09/2017

DIA Biosimilars Conference 2017
24−25 October 2017
Hyatt Regency
Bethesda, MD, USA

DIA's Biosimilars Conference is the premier location to better understand new and innovative ways biosimilar policies and requirements are evolving.

The science of biosimilars continues to evolve, and development programmes 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 WHO
  • Direct discussion with patients, prescribers, and payers on how these stakeholders perceive the value of biosimilars
  • Focus on the post-market phase of biosimilars, from fundamental life-cycle management issues and differences from original biologicals 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 programme
  • Post-market life-cycle management of biosimilars and differences from original biologicals: manufacturing changes, labelling 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

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