Overview
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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
Moving Toward Clarity on Biosimilar InterchangeabilityOn Demand
The term "interchangeable" when applied to biosimilars has different meanings in different parts of the world. This webinar will provide a review of terminology, including differences in US and EU, definitions of interchangeability, and regulatory and legal frameworks as they relate to substitution of biologics.
Download the Recording Today!
Program Committee
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Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Hillel P Cohen, PhD Biosimilars Expert
Retired, United States -
Thomas Felix, MD Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Amgen Inc., United States -
Julie Marechal-Jamil, MSc Director, Biosimilar Policy and Science
Medicines For Europe, Belgium -
Laura McKinley, PhD Director, Global Regulatory Policy and Intelligence
Pfizer Inc, United States -
Cecil J. Nick, MS FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom -
John Pakulski, RPh Senior Vice President, Global Regulatory Affairs
Kashiv BioSciences LLC, United States -
Juliana Marguerite Reed, MS Executive Director
The Biosimilars Forum, United States
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