Overview
Short Course: October 4
Conference: October 5-6
The Biosimilars Price Competition and Innovation Act (BCPIA) created a biosimilars approval pathway in the US with the goal of increasing access to safe, effective, and cost effective biological treatment options for patients. To date, significant progress has been made in the science and regulation of biosimilar development and approval but barriers still exist to a robust biosimilars market. The current ongoing challenges are legal complications to the launch of a biosimilar, the persistence of misinformation and disparagement, and delays in the creation of policies that increase patient access. The challenges have been and continue to be complex, interrelated, and best addressed by stakeholder collaboration, not only within the US but across global regions.
The development of biosimilars has been maintained by the prospect of cost savings to patients and possible improvement over the competition. To improve their market share, stakeholders are now focusing on streamlining biosimilars development, meeting ongoing manufacturing challenges, , addressing pricing issues, and educating prescriber and patients on the benefits of biosimilars. At the DIA 2021 Biosimilars Conference, manufacturers, regulators, payers, prescribers, and patients will come together to discuss factors that influence biosimilar development and access and to share perspectives on what success and equilibrium will look like. They’ll apply the newest thinking and relevant learnings from global regions to build strategies for continuing the growth of the biosimilars market and bringing these important biologic therapies – and cost savings - to patients.
Program Committee
-
Hillel P Cohen, PhD Executive Director, Scientific Affairs
Sandoz Inc., United States -
Tiffany Fletcher, MA Head of Global Access Policy
Viatris, United States -
Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Emanuela Lacana, PhD Deputy Director, OTBB, OND, CDER
FDA, United States -
Julie Marechal-Jamil, MSc Director, Biosimilar Policy and Science
Medicines For Europe, Belgium -
Stanton Mehr Director of Content
Biosimilars Review and Report, United States -
Cecil J. Nick, MS FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom -
Juliana Marguerite Reed, MS Executive Director
The Biosimilars Forum, United States -
Laura D. Wingate Executive Vice President, Education, Support, and Advocacy
Crohn's & Colitis Foundation, United States -
Sarah Yim, MD Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
FDA, United States -
Representative Invited Test, United States
-
Lu-Ning Cui, MD, PhD Senior Clinical Evaluator, HPFB
Health Canada, Canada
Have an account?