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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 Interchangeability 
On 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!

Who should attend?

Professionals involved in:

  • Biosimilar/Biologic Pharmaceuticals
  • Biomedical Product Development and Manufacturing
  • Regulatory Affairs
  • Clinical and Nonclinical Research
  • Biostatistics and Data Management
  • Business Development
  • Marketing and Commercialization
  • Medical Communications/MSLs
  • Patient Advocacy/Patient Support Programs

Learning objectives

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

  • Describe recent advances in powerful analytic techniques for demonstrating biochemical, physicochemical, and functional similarity of molecules
  • Explain how regulators and sponsors justify or reject molecular and functional differences
  • Identify the procedural changes necessary to adhere to the US FDA final naming guidance for biologics and their system-wide impact on stakeholders
  • Assess the impact of the implementation of BsUFA II provisions on biosimilar development and approval processes
  • Discuss the range of perspectives of patients, payers, and prescribers on the use of biosimilar therapies
  • Analyze how international policy and regulatory developments may affect local biosimilar programs
  • Compare and contrast the life cycle management of a biosimilar with that of an original biologic
  • Define the US expectations for demonstration of interchangeability

Program Committee

  • Leah  Christl, PhD
    Leah Christl, PhD Executive Director, Global Regulatory and R&D Policy
    Amgen, United States
  • Hillel  Cohen, PhD
    Hillel Cohen, PhD Executive Director, Scientific Affairs
    Sandoz Inc., United States
  • Thomas  Felix, MD
    Thomas Felix, MD Medical Director, R&D Policy, Global Regulatory Affairs and Safety
    Amgen Inc., United States
  • Julie  Marechal-Jamil, MSc
    Julie Marechal-Jamil, MSc Director, Biosimilar Policy & Science
    Medicines For Europe, Belgium
  • Laura  McKinley, PhD
    Laura McKinley, PhD Director, Global Regulatory Policy & Intelligence
    Pfizer, Inc., United States
  • Cecil J. Nick, MS
    Cecil J. Nick, MS FTOPRA, Vice President (Technical)
    PAREXEL Consulting, United Kingdom
  • John  Pakulski, RPh
    John Pakulski, RPh Head, Regulatory Science, Biologics
    Mylan Inc., United States
  • Juliana Marguerite Reed, MS
    Juliana Marguerite Reed, MS Vice President, Corporate Affairs, Global I & I and Biosimilars Lead
    Pfizer, Inc., United States
  • Emily  Shacter, PhD
    Emily Shacter, PhD Independent Consultant
    ThinkFDA, LLC, United States
  • Cornelia  Ulm
    Cornelia Ulm Head of Regulatory Affairs, Biosimilars
    Fresenius Kabi, Switzerland
  • Jian  Wang, MD, PhD
    Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
    Health Canada, Canada
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On-Demand Complimentary Webinar

Moving Toward Clarity on Biosimilar Interchangeability

Key Development, Market, and Regulatory Changes You Cannot Ignore: A Guide

Download Guide

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