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Overview

October 23: Short Course: Navigating Through the Challenges and Pitfalls of Biosimilar Development
October 24-25: Conference


The Biosimilars Price Competition and Innovation Act (BCPIA) of 2009 created a biosimilars approval pathway in the US with the goal of increasing access to effective biological treatment options while reducing health care costs. At the DIA Biosimilars Conference in 2012, Dr. Janet Woodcock told attendees “biosimilars represent a paradigm shift in the way we make a finding of safety and efficacy.”

Since that time, significant progress has been made in the science and regulation of biosimilar development and approval, and cooperative efforts of the US, EU, Canada, and other regions is leading to better global alignment on evolving scientific and regulatory issues.

Dr. Woodcock also presaged that it would “require a cultural and cognitive transformation” to realize the promise of biosimilars. To address the uptake barriers that still exist, even in regions with years of biosimilar market experience, clinician, patient, and other stakeholders must be engaged.

DIA’s Biosimilars Conference will bring these stakeholders together to share the latest advances in biosimilar science, regulation, global alignment, education, and access. The consideration of issues from all perspectives in this open, neutral environment will better inform the decisions participants must make in their own biosimilar programs today.


Complimentary Webinar

Moving Toward Clarity on Biosimilar Interchangeability
September 24 | 11:00AM-12:00PM ET
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.
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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
  • Describe how regulators and sponsors justify or reject molecular and functional differences
  • Discuss the procedural changes necessary to adhere to the US FDA final naming guidance for biologics and their system-wide impact on stakeholders
  • Identify 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/contrast the life cycle management of a biosimilar with that of an original biologic
  • Express a broad understanding of US expectations for demonstration of interchangeability

Program Committee

  • Leah  Christl, PhD
    Leah Christl, PhD Associate Director for Therapeutic Biologics, TBBS, OND, CDER
    FDA, 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 Biosimilars Policy & Science
    Medicines For Europe, Belgium
  • Laura  McKinley, PhD
    Laura McKinley, PhD Director, US Regulatory Policy Lead, Pfizer Essential Health
    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, Government Affairs
    Coherus BioSciences, United States
  • Emily  Shacter, PhD
    Emily Shacter, PhD Independent Consultant
    ThinkFDA, LLC, United States
  • Cornelia  Ulm
    Cornelia Ulm Head of Regulatory Affairs, Biosimilars
    Merck Biopharma, Switzerland
  • Jian  Wang, MD, PhD
    Jian Wang, MD, PhD Chief, Clinical Evaluation Division - Haematology/Oncology, HPFB
    Health Canada, Canada
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Contact us

Questions?

1.888.257.6457


Complimentary Webinar

Moving Toward Clarity on Biosimilar Interchangeability | Sept. 14


Short Course

Navigating Through the Challenges and Pitfalls of Biosimilar Development


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

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Digital Learning Catalog

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