The Future of the U.S. Biosimilars Market:
Development, Education, and Utilization
Tuesday, October 18, 2016 – 9:00am – 1:00pm
Ritz-Carlton (Venue Change)
1150 22nd St NW
Washington, DC
Salon 1 & 2
On October 18, 2016, Friends of Cancer Research (Friends) and the Duke-Margolis Center for Health Policy held a forum on biosimilars titled: The Future of the U.S. Biosimilars Market: Development, Education, and Utilization. The half-day forum brought together clinicians, originator and biosimilar drug sponsors, advocates, regulators, and payers to tackle remaining uncertainty surrounding the future of the U.S. biosimilars market.
The forum was divided into two sessions focusing on the current landscape of biosimilars development, regulatory review, and stakeholder education and addressing challenges in clinical decision-making, coverage and reimbursement, and postmarket evidence development, respectively.
The first session discussed the FDA’s regulatory review process for biosimilars and manufacturer experiences with developing biosimilars. The multi-stakeholder panel discussed potential requirements to demonstrate interchangeability and the educational efforts needed to optimize biosimilar uptake.
L-R: Robert Rifkin, Emily Alexander, Lisa Bell, Leah Christl,
Kristen Santiago, Carlos Sattler, Kimberly Wright
The second session consisted of a panel discussion around how biosimilars may be prescribed and dispensed to patients, and the impact coverage and reimbursement decisions will ultimately have on the utilization of biosimilars in the U.S.
L-R: Mark McClellan, Jeff Eicholz, Richard Schilsky, Elaine Daniels, Andrea Ferris, Kevin Haynes
In preparation for this meeting, multi-stakeholder working groups developed a booklet consisting of two whitepapers providing a landscape analysis of biosimilar development, education, and utilization in the U.S. The booklet may be viewed here: https://friendsofcancerresearch.org/wp-content/uploads/The-Future-of-U.S.-Biosimilars_0.pdf.
Meeting Agenda
9:00 a.m. – Welcome and Introduction
- Jeff Allen, Friends of Cancer Research
9:10 a.m. – Session I: The Current Landscape of Biosimilars Development, Regulatory Review, and Stakeholder Education
9:10 a.m. – FDA’s Perspective on the Regulation of Biosimilars
- Leah Christl, U.S. Food and Drug Administration
9:30 a.m. – Manufacturer Experiences with Biosimilar Development
- Carlos Sattler, Sandoz, Inc.
9:50 a.m. – Panel Discussion
- Moderator: Robert Rifkin, The U.S. Oncology Network
- Emily Alexander, AbbVie, Inc.
- Lisa Bell, Coherus BioSciences
- Leah Christl, U.S. Food and Drug Administration
- Kristen Santiago, Cancer Support Community
- Carlos Sattler, Sandoz, Inc.
- Kimberly Wright, Susan G. Komen
10:50 a.m. – Break
11:00 a.m. – Session II: Addressing Challenges in Clinical Decision-Making, Coverage and Reimbursement, and Postmarket Evidence Development
- Moderator: Mark McClellan, Robert J. Margolis, MD, Center for Health Policy at Duke University
- Elaine Daniels, Pfizer
- Jeff Eichholz, Express Scripts
- Andrea Ferris, Lungevity
- Kevin Haynes, HealthCore LLC
- Richard Schilsky, American Society of Clinical Oncology
12:00 p.m. – Moderated Discussion and Audience Q&A
12:30 p.m. – Closing Remarks
- Mark McClellan, Robert J. Margolis, MD, Center for Health Policy at Duke University
