Biosimilars Conference

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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

At the end of this conference participants should be able to:

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 • Biosimilars
Pfizer, 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