Join the “who’s who” of the biosimilars and innovator biologics industries in Boston in June 2023.
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, 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 14th Summit on Biosimilars & Innovator Biologics and contemplate these and other probing questions.
Charles K. Sholtz, PhD, JD
Director and AGC, Manufacturing IP Lead
Genentech | A Member of the Roche Group
“With the approval of the first two interchangeable biosimilar in the past year, and several more on the horizon, we are entering a new era of biosimilar medicines in the United States. Join us as we tackle topics ranging from intellectual property, to regulatory, to antitrust, to pricing/ reimbursement, and be part of the conversation about how the industry collectively ensures that everyone with a serious disease can get the treatment they need.”
VP, Head Regulatory Strategy and Policy
“While we are buffeted by international news about pandemics and wars, there remains a critically important job for us to do. And that is to make cost-effective quality medicines available to patients. Fortunately, Covid has confirmed that the science is truly a global language and biologics can be made and distributed worldwide. The regulatory and legal environments can support this or confound it. At this meeting you will see how efforts are evolving to support a fair competitive environment that encourages both originator biologics and biosimilars – after all the former are the future for the latter, and the US is the single biggest biologics market in the world by value.”
2022 Key Speakers
M. Stacey Ricci
Director, Scientific Review Staff
Office of Therapeutic Biologics and Biosimilars
U.S. Food and Drug Administration
Hon. Michelle Ankenbrand
Senior Lead Administrative Patent Judge, PTAB
Attorney, Bureau of Competition
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as non-transitional for the purposes of CLE accreditation. Learn more
Who You Will Meet
In-house counsel from branded and biosimilars companies
Government representatives from the FDA, USPTO, and the Judiciary
Leading regulatory and patent attorneys from around the country
About this Conference
Prepare to enter the next decade of this revolutionary law.
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The incorporation of biosimilar products into the U.S. marketplace was designed to improve patient access and decrease healthcare costs. While much has evolved since the enactment of the BPCIA, the traditional barriers remain.
Now, more than ever, strategies to overcome these barriers are essential to improve the understanding of biosimilar products in the United States. The need for a solid guiding framework becomes more critical than ever before.
The next decade will see more litigation in this sphere. Further, and to an increasing extent, IPR proceedings challenging patents protecting biologic medicines, including IPRs filed before any action was taken under the BPCIA. Finally, the future will usher in considerable changes growing the scope of products that are regulated and litigated under the BPCIA.
Join the “who’s who” of the biosimilars and innovator biologics industries as they gather virtually to discuss and contemplate the impact of these critical developments.