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The Biosimilars Price Competition and Innovation Act (BCPIA) of 2009 created a biosimilars approval pathway in the US with the goal of increasing access safe and effective biological treatment options that are more cost effective than standard biologics. Since then, significant progress has been made in the science and regulation of biosimilar development and approval, and cooperative efforts among global regions is leading to better alignment on these issues.

To date, the FDA has approved 18 biosimilars, yet only seven are currently available on the market. Though this represents roughly a doubling of the marketed products in the past year, in the US especially, uptake of biosimilars has been slower than anticipated. Barriers to a robust biosimilars market are well understood:

  • Commercial challenges such as restrictive formularies, contracting, rebates, and other pricing issues
  • Legal challenges including extensive patent estates, unresolved questions from BPCIA, and settlements between originator and biosimilar companies
  • Educational needs for healthcare providers and patients about the effectiveness and safety of biosimilars

These challenges are complex, interrelated, and best addressed by stakeholder collaboration. At DIA's Biosimilars Conference, manufacturers, regulators, payers, prescribers, and patients will come together to apply current biosimilar developments, experience, and the newest thinking to analyze strategies and next steps for improving biosimilar access and uptake.

Check out our 2019 Program!

Who should attend?

Professionals involved in:

  • Biosimilar/Biologic Pharmaceuticals
  • Biomedical Product Development and Manufacturing
  • Regulatory Affairs Professionals
  • Clinical and Nonclinical Research
  • Biostatistics and Data Management
  • Business Development Executives
  • Marketing and Commercialization Staff involved with biosimilars
  • Medical Communications/MSLs
  • Patient Advocacy/Patient Support Programs
  • Physicians including specialists across therapeutic disciplines
  • Pharmacists and pharmacy professionals
  • Payors, pharmacy benefit managers, insurers, health plans

Learning objectives

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

  • Identify the current barriers to access and uptake facing biosimilars in the US
  • Describe the US reimbursement and pricing landscape and its impact on market uptake and sustainability of biosimilars and interchangeable biological products
  • Discuss educational needs of healthcare providers and patients around biosimilars/interchangeable biologicals and current strategies for increasing literacy on these products
  • Explain the role of legal challenges such as patent litigation in influencing access to biosimilars
  • Discuss current developments in regulatory and scientific issues and their impact on access and uptake of biosimilars and interchangeable products
  • Discuss strategies and stakeholder-specific next steps to address these challenges

Program Committee

  • Hillel  Cohen, PhD
    Hillel Cohen, PhD Executive Director, Scientific Affairs
    Sandoz 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 and Intelligence
    Pfizer Inc, United States
  • Cecil J. Nick, MS
    Cecil J. Nick, MS FTOPRA, Vice President (Technical)
    Parexel Consulting, United Kingdom
  • Mark  Stewart, PhD
    Mark Stewart, PhD Vice President, Science Policy
    Friends of Cancer Research, United States
  • Jian  Wang, MD, PhD
    Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
    Health Canada, Canada
  • Anna  Welch, MA
    Anna Welch, MA Chief Editor, Biosimilar Development
    Life Science Connect, United States
  • Sarah  Yim, MD
    Sarah Yim, MD Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
    FDA, United States
  • Mary Jo  Carden, JD, RPh
    Mary Jo Carden, JD, RPh Head, Policy
    Sandoz, Inc., United States
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Check out our 2019 Program!

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