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Virtual

Oct 01, 2025 12:00 PM - Oct 01, 2025 1:00 PM

(US Eastern Standard Time)

Unleash the Power of Biosimilars: Navigating the Regulatory Landscape for Transformative Therapies

A discussion on the regulatory challenges to biosimilar development and uptake in the global market today.

Overview

This webinar is brought to you by DIA in cooperation with


Arnold Ventures is a philanthropy that supports research to understand the root causes of America’s most persistent and pressing problems, as well as evidence-based solutions to address them. By focusing on systemic change, AV is working to improve the lives of American families, strengthen their communities, and promote their economic opportunity. Since Laura and John Arnold launched their foundation in 2008, the philanthropy has expanded, and Arnold Ventures’ focus areas include education, criminal justice, health, infrastructure, and public finance, advocating for bipartisan policy reforms that will lead to lasting, scalable change. The Arnolds became signatories of the Giving Pledge in 2010.


The global biosimilars market has been projected to reach $1.3 trillion by 2032. Biosimilars offer lower prices and greater therapeutic options in the marketplace, strengthening competition and helping reduce health spending. Today, there are over 50 biosimilars approved in the United States and over 120 biosimilars approved in Europe. However, only about 10% of the over 100 biologics expected to lose market exclusivity in the next decade have a biosimilar currently under development. This session will examine the regulatory challenges to biosimilar development and uptake in the global market today, focusing on a comparative analysis between the Europe and the United States.

Featured topics

  • Interchangeability
  • Naming convention
  • Patent thickets

Who should attend?

Professionals who work in the area of:

  • Biotechnology
  • Comparative Effectiveness/Health Technology Assessment
  • Combination Products
  • Clinical Safety/Pharmacovigilance
  • Clinical Research
  • Clinical Supplies
  • Good Clinical Practice
  • Manufacturing
  • Pharmacology
  • Professional Education, Training & Development
  • Project Management
  • Public Policy, Health Care, Compliance Law
  • Public Policy/Law/Corp. Compliance
  • Pricing/Reimbursement
  • Patient Engagement
  • Quality Assurance, Control
  • Regulatory Affairs
  • Research & Development
  • Rare, Orphan Diseases
  • Strategic Planning
  • Submissions

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