Discuss the future of biosimilars and formulate solutions to the complex regulatory and patent challenges ahead with industry leaders from both innovator and biosimilar companies

Network with leading counsel representing both biosimilar and innovator companies at the industry’s one and only event directed to the legal, regulatory, and commercial aspects of the biosimilars marketplace.

Ten years ago, the Biologics Price Competition and Innovation Act (BPCIA), was signed into law paving the way for the creation of biosimilars. That same year, ACI launched its inaugural Biosmilars Summit.

June 2019 marks the 10th anniversary of this event

Join the “who’s who” of the biosimilars and innovator biologics industries as they gather in New York for ACI’s 2019 Summit on Biosimilars.

We are pleased to announce the following new exciting additions to the speaker roster at our 10th anniversary event.

Exclusive Interview on Interchangeability with:
Joseph Franklin
Associate Director for Policy, Therapeutic Biologics and Biosimilars Staff
Office of New Drugs, CDER

U.S. Food & Drug Administration

Maureen Bresnahan
Assistant General Counsel
Eisai (Andover, MA)

Laura Storto
Assistant General Counsel, Associate Director

Immac “Casey” Thampoe
Executive Director/Assistant General Counsel
IP Portfolio Development

Regeneron Pharmaceuticals, Inc.

Tara Rahemba
Senior Director, Patent Counsel
Alexion Pharmaceuticals, Inc.

Benefit from the insights of leading policy and decision-makers on all aspects of the design and execution of effective biosimilars commercialization.

Association Insights from:
  • Association for Accessible Medicines (AAM)
  • Biotechnology Innovation Organization
  • PhRMA
Industry Insights from:
  • Alexion Pharmaceuticals.
  • Apotex
  • Eisai
  • Genentech
  • Regeneron Pharmaceuitcals
  • Sandoz
  • Takeda Pharma
  • Teva Pharmaceuticals


  • Interchangeability: Insights into FDA’s Perspective on Implementation and the Future of Policy Development
  • The Economics of Biosimilar Drugs: New Considerations for Market Access, Sustainable Pricing and Reimbursement Policies
  • Global Focus on Biosimilars Abroad: From Patent Protection to Cost and Market Access
  • Challenging Patents on Reference Drugs and Establishing Standing: Litigation Strategies in the IPR Forum
  • The ITC: Examining the Role of this Alternate Forum in Biosimilars Disputes
  • The Growing Antitrust Scrutiny of Biosimilars and Biologics and Related Settlement Considerations

Don’t miss your opportunity to save with Early Bird rates!

Register now and be part of the prestigious meeting of the minds.

stay up-to-date by signing up for email updates.

Enhance your learning and networking experiences by attending the post-conference workshops on June 26, 2019

 ACI’s Annual Summit on Biosimilars is always very informative – the balance of innovators and biosimilars is key.  
– Counsel, Patterson Belknap
 Excellent insights into cutting edge issues. I learned a lot and I enjoyed hearing from thought leaders in the biosimilar field. I’ll be back next year!  
– Associate, Fish & Richardson P.C.
 ACI’s Summit on Biosimilars allows you to catch up on a year of changes to the biosimilar space in two days and provides good opportunities to network.  
–Partner, K&L Gates, LLP

Event Contacts

For sponsorship opportunities please contact:
American Conference Institute
[email protected]

For media partnership opportunities please contact:
Linda Lam
Tel: 212-352-3220 ext. 5238
[email protected]

For questions about this year’s program/content, or information on how you can speak next year please contact:
Joseph Gallagher
Tel: 212-352-3220 ext. 5511
[email protected]