Biosimilar Market Retrospective

Unpacking the Humira and Non-Humira Biosimilar Launches and Lawsuits: Lessons Learned and Insights for the Future

June 20, 2024 10:00am

Craig Burton
Executive Director | Senior Vice President, Policy and Strategic Alliances
Biosimilars Council | Association for Accessible Medicines

Paul Walden, Ph.D
Vice-President, Medical Affairs
Celltrion Healthcare Co., Ltd.

Robert Cerwinski
Managing Partner
Gemini Law LLP

Anita Varma
Partner
White & Case LLP

14 years have passed since the Biologics Price Competition and Innovation Act was signed into law, and more than a year since Amgen’s Amjevita launched, the first in a string of nine Humira biosimilars. In this retrospective, industry stakeholders will assess the trends, market uptake, and lessons learned from both the Humira and non-Humira biosimilar launches and lawsuits, offering strategies for designing forward-thinking portfolio strategies. Topics of discussion include:

  • Exploring which biosimilars have seen “successful” market uptake across product class, applications, and geography
  • Reviewing the Adalimumab BPCIA biosimilars and identifying market dynamics, pricing strategies, and other factors influencing uptake disparities
    • Assessing why the higher-priced Amjevita saw higher uptake than the lower-priced Amjevita
  • Assessing the impact of interchangeable status on biosimilar uptake
  • Reflecting on approved and marketed biosimilars while looking ahead and considering clinical insights, manufacturing needs, pricing and dosages for pipeline development