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

October 1, 2025 | 12:00pm-1:00pm ET 

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Company Overview

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.

Webinar Overview

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
 
Speakers:
 
  • Marina Socal,  MD, PhD, MS, MPP

    Mariana Socal is an Associate Professor of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins Carey Business School. Professor Socal researches ways to improve access and affordability of prescription drugs, including the global pharmaceutical supply chain, gene therapies, generics, and biosimilar markets. Professor Socal has testified before the U.S. Congress and the Food and Drug Administration on biopharmaceutical regulation. She is a member of the World Health Organization's Technical Advisory Group on Pricing Policies for Medicines. Professor Socal is a Neurologist. She has a Master’s in Public Policy from Princeton University and a PhD in Health Systems from Johns Hopkins University.

    speaker 1

  • Rachel Goode ,JD, PhD
    Dr Rachel Goode is the Senior Vice President, Head of Legal and Intellectual Property at Fresenius Kabi Biopharmaceuticals, where she leads a global team of attorneys and oversees the patent and legal strategy for biosimilars. Dr. Goode has authored multiple peer-reviewed publications and has testified before the U.S. Senate Committee on the Judiciary, advocating for reforms to the patent system to support biosimilar access. Dr. Goode previously served as counsel for the biosimilars division at Teva and Patents Lead for biosimilar products at EMD Serono. Dr. Goode is licensed to practice law in Washington, D.C. and is a registered patent attorney in the United Kingdom and Europe. She holds a Ph.D. in Molecular Biology. 

    speaker 2

  • Antonio Trujillo, PhD

    Professor Antonio Trujillo is an applied health economist known for his work on enhancing medication accessibility in the U.S. and globally. He concentrates on strategies to bolster market competition and broaden access to generics and biosimilars. He examines antitrust issues, including "pay for delay" and “mergers,” to decipher the underlying factors contributing to market inefficiencies. Trujillo’s work offers a framework for researchers using the concept of fair pricing in innovative drug pricing policy. Currently, Trujillo researches policies to promote brand-to-brand competition and expedite the introduction of biosimilars. Trujillo is the Director of the Master of Health Science in Global Health Economics program.

    Speaker 3
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, 
    Quality Assurance, Control, Regulatory Affairs, Research & Development, Rare, Orphan Diseases, Strategic Planning,  Submissions 

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