Explore Legal, Regulatory, Commercial Strategies for Innovator & Biosimilars Marketplace this June

Government Speakers at ACI's Summit on Biosimilars
Government Speakers at ACI's Summit on Biosimilars
BOSTON - May 25, 2022 - PRLog -- American Conference Institute (ACI) is pleased to announce that Charles K. Sholtz, Director and AGC, Manufacturing IP Lead, Intellectual Property at Genentech and Gillian Woollett, Vice President, Head Regulatory Strategy and Policy at Samsung Bioepis will be co-chairing the 13th Annual Summit on Biosimilars & Innovator Biologics. The event will focus on legal, regulatory, and commercial strategies for the innovator and biosimilar marketplace at the Hyatt Regency Boston on June 28-29, 2022.

Biosimilars and innovator biologics are among the most groundbreaking therapies that treat many life-threatening conditions. However, even with a calendar year that included 4 FDA approvals, 3 launches in the United Sates, 2 approvals for interchangeable biosimilars, and several regulatory and legal developments, the traditional barriers continue to be complicated, interconnected, and best addressed by stakeholder collaboration.

Gillian Woolett explains, "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."

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.

With this context, ACI's conference was created to further explore the contours of the rapidly changing landscape for biosimilars and innovator biologics, and to provide insights from government representatives from USPTO, FDA and FTC, In-House Counsel and Leading Regulatory and Patent Attorneys from around the country.

For more details, including a full agenda, faculty lists, and brochure, visit:


A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the U.S., and around the world.

Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.

Headquartered in New York, ACI has grown to produce more than 100 events each year, attended by thousands of senior delegates from across the world.
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