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.
Who should attend?
Professionals involved in: Senior Level Professionals and Decision-makers involved in:
- Biosimilar/Biologic Pharmaceutical Research
- Biomedical Product Development and Manufacturing
- Regulatory Affairs
- Clinical and Nonclinical Research
- Biostatistics and Data Management
- Business Development
- Marketing and Commercialization for biosimilars
- Medical Communications/MSLs
- Patient Advocacy/Patient Support Programs
- Health and medical care across therapeutic disciplines
- Health Education
- Provision of prescription products
- Development and management of prescription product formularies
- Development and management of prescription benefit plans
Learning objectives
- Discuss current developments in regulatory and scientific issues and their impact on development, manufacturing, access, and uptake of biosimilars and interchangeable products
- Discuss imperative and progress in streamlining biosimilar development
- Describe the impact of the approval of the first interchangeable biosimilar from a scientific and policy perspective
- Examine current prescriber and patient confidence and patterns of biosimilar use, and education efforts that have been successful in increasing literacy on these products
- Describe relevant international developments influencing patterns of biosimilar uptake globally
- Discuss new opportunities for product differentiation and utilization of regulatory flexibility
- Describe the status of biosimilar product development, availability, and uptake in the US
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 & 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 • United States
-
Lu-Ning Cui, MD, PhD • Senior Clinical Evaluator, HPFB
Health Canada, Canada
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Differentiating Your Biosimilar From the Crowd
Additional Information
Sign up to be notified when registration opens for the DIA 2022 Events
Biosimilars Resource Kit