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.
Check out all session descriptions and speakers for this year's virtual 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 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.
- 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
- 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
- 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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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
Leah Christl, PhD • Executive Director, Global Regulatory and R&D Policy
Amgen, United States
Hillel Cohen, PhD • Executive Director, Scientific Affairs
Sandoz Inc., 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 & Science
Medicines For Europe, Belgium
Laura McKinley, PhD • Director, US Regulatory Policy Lead, Pfizer Essential Health
Pfizer, Inc., United States
Cecil J. Nick, MS • FTOPRA, Vice President (Technical)
PAREXEL Consulting, United Kingdom
Jian Wang, MD, PhD • Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada