As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 12th Annual Biosimilars & Innovator Biologics Summit.
As the number of FDA-approved biosimilar products continues to grow, the need for a solid guiding framework becomes more critical than ever before. While the stakeholders wait for finality on the rules governing significant matters like interchangeability, substitution and equivalency, it is clear that biosimilars will remain a top priority for the FDA.
The biosimilars market continues to maintain momentum as we head into 2021, but questions remain as to whether the U.S. market will catch up with Europe and whether biosimilars will provide their intended cost-savings.
Join the “who’s who” of the biosimilars and innovator biologics industries as they gather for ACI’s 2021 Summit on Biosimilars & Innovator Biologics, and contemplate these and other probing questions.
GOVERNMENT INSIGHTS FROM
Assistant Director, Health Care Division
Bureau of Competition
Acting Director, Policy Staff
Office of Therapeutic Biologics and Biosimilars
Office of New Drugs, CDER
Hon. Jacqueline Wright Bonilla
Deputy Chief Judge
Hon. Michelle Ankenbrand
Lead Administrative Patent Judge
Hon. Kristi Sawert
Administrative Patent Judge PTAB
Who You Will Meet
In-house counsel from branded and biosimilars companies
from the FDA, USPTO, and the Judiciary
Leading regulatory and patent attorneys from around the country
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.
Immac “Casey” Thampoe
Executive Director/Assistant General Counsel
IP Portfolio Development
Regeneron Pharmaceuticals, Inc.
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.
Charles K. Sholtz
Director and Associate General Counsel
Biosimilars, Manufacturing & Litigation Readiness Lead
ACI’s Global Series of Life Sciences Conferences bring together key sector stakeholders from around the globe to explore the most important trends impacting the many industries including pharmaceutical, biotechnology, medical device/diagnostics, and FDA-regulated consumer products. Our events cover every facet of legal and business relevance as well as controversy. Learn More