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DIA’s Biosimilars Program Committee presents the first DIA Biosimilars Virtual Conference!

Created and curated by experts from our Biosimilars Program Committee, the DIA Biosimilars Virtual Conference is comprised of three sessions: Barriers to Uptake of Biosimilars in the US, Biosimilar Reimbursement in the US Marketplace, and Biosimilars in China. These sessions are available in both a live and on-demand format, and can be enjoyed in the comfort of your home or office at your convenience.

Program Available!

Biosimilars Virtual ConferenceCheck out all session descriptions and speakers for this year's virtual conference!

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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 as well.

To date, FDA has approved 10 biosimilars, yet only three are currently available on the market. Furthermore, in the US and in other regions, uptake of biosimilars has been less than initially anticipated. The barriers to realizing the promise of biosimilars are numerous, and in the US extend to reimbursement policies. Global development has been slowed by prohibitive regulations and guidelines in some regions such as China.

DIA’s Biosimilars Virtual Conference presents three sessions (see below for featured topics) that will examine the forces influencing the future of biosimilars for stakeholders in the US – from global developers to healthcare providers to patients.

Barriers to Uptake of Biosimilars in the US
Biosimilar Reimbursement in the US Marketplace
Biosimilars in China
October 17 | 9:00-10:30AM ET

Experts will delve into the adaptation of the US biosimilars landscape to address uptake barriers in the US and explore the implications of recent reimbursement policies on biosimilar utilization. The impact of the changing China regulatory environment on the potential of biosimilars and opportunities for inclusion of that country as a target region for global development will be examined.

Barriers to Uptake of Biosimilars in the US

  • Lack of understanding: Perception challenges and misinformation around safety, effectiveness, extrapolation, quality, and interchangeability
  • Commercial challenges: Educating health system stakeholders, restrictive formularies, contracting, and rebates
  • Legal challenges: Extensive patent estates, unresolved questions from BPCIA, and settlements between originator and biosimilar companies

Biosimilar Reimbursement in the US Marketplace

  • Payments for biosimilars under Medicare Part B: J-code, pass-through, implications, and key outstanding issues
  • Payments for biosimilars under Medicare Part D: Coverage gap, cost-sharing changes, implications, and key outstanding issues
  • Biosimilars to be subject to changes to 340B drug pricing

Biosimilars in China

  • Biosimilar market in China: Potential, changing regulatory environment, clearing hurdles, and reimbursement
  • Overall regulatory strategy: Raising data standards and alignment with international requirements, CTA process and timeline, and MAA process and timeline
  • China regulatory strategy for biosimilar development: Review of existing and newly issued guidelines, Phase 1 PK study requirements, Phase 3 clinical trial requirements, and more on biosimilar Avastin (bevacizumab) and Herceptin (Trastuzumab) clinical design, and review considerations and the technical requirements of acceptance of foreign clinical data (draft)

Want More?

Check out our latest interview podcast from the DIA 2018 Global Annual Meeting with Nielsen Hobbs after he chaired the session, “Interchangeable Biosimilars: A Global Perspective.”
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Learning objectives

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

  • Describe the current barriers to uptake facing biosimilars in the US
  • Discuss how the US biosimilar landscape may evolve in the future to address these challenges
  • Describe the US reimbursement landscape for biosimilars and interchangeable biological products
  • Assess the impact of reimbursement policies on market uptake and sustainability of biosimilars and interchangeable biological products
  • Assess the potential for biosimilars in China
  • Explain navigation of the Chinese regulatory system with respect to gaining biosimilar approval
  • Describe the design a global clinical development program that meets the Chinese regulatory requirements

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 and Intelligence
    Pfizer Inc, United States
  • Cecil J. Nick, MS
    Cecil J. Nick, MS FTOPRA, Vice President (Technical)
    Parexel Consulting, United Kingdom
  • Jian  Wang, MD, PhD
    Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
    Health Canada, Canada
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Individual Sessions

Session 1: Barriers to Uptake of Biosimilars in the US | On-Demand

Session 2: Biosimilar Reimbursement in the US Marketplace | On-Demand

Session 3: Biosimilars in China | October 17 | 9:00-10:30AM ET

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