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

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA) which paved the way for the creation of biosimilars. ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we prepare to enter the next decade of this iconoclastic law, we cordially invite you to join us for the 10th Anniversary edition of ACI’s Biosimilars Summit.


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


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

Regeneron Pharmaceuticals, Inc.
 Year after year, the ACI Biosimilar Conference has featured a top-notch faculty from the pharma/biotech industry, private practice and government to address hot-button issues in this rapidly evolving area — I am looking forward to another outstanding event.  

Charles K. Sholtz
Director and Associate General Counsel
Biosimilars, Manufacturing & Litigation Readiness Lead

 If I had to pick only one event to get the latest on issues impacting biosimilars, it would be the ACI Biosimilar Conference — highly informative presentations and ample opportunities to network and catch-up with players in this space.  
Exclusive Interviews with:

Joseph Franklin
Associate Director for Policy, Therapeutic Biologics and Biosimilars Staff Office of New Drugs, CDER
U.S. Food & Drug Administration

The Honorable Jacqueline Bonilla
Deputy Chief Judge
Patent Trial and Appeal Board

U.S. Patent & Trademark Office

Featured In-House Speakers:

Maureen Bresnahan
Assistant General Counsel

Laura Storto
Assistant General Counsel, Associate Director

Laura Sim
Sr. Counsel
Development, Regulatory, Operations, & Contracting Law


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
  • Amgen
  • Apotex
  • Eisai
  • Genentech
  • Regeneron Pharmaceuticals
  • 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.


 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

New York Marriott East Side Hotel