American Conference Institute’s 15th Annual Summit on Biosimilars and Innovator Biologics will provide you with practical insights and advanced strategies for overcoming hurdles in the three critical pillars applicable to this industry: Legal, Regulatory and Commercialization. This event brings together the “who’s who” of the biosimilars and innovator biologic industries and attendance is not optional.

Featured Speakers
Speaker

Ali I. Ahmed

Senior Vice President, BioPharma
Fresenius Kabi, USA

Speaker

Craig Burton

Executive Director | Senior Vice President, Policy and Strategic Alliances
Biosimilars Council | Association for Accessible Medicines

Speaker

Larry Coury

Vice-President, Associate General Counsel
Regeneron Pharmaceuticals

2024 is a critical year – the industry has matured since the implementation of the BPCIA, with a significant increase in lawsuits within this space and the Humira biosimilar launches in 2023, revealing unexpected deviations from anticipated trends and insights for the future.

2024 Highlights Include:

A two-part retrospective on the evolution of the biosimilars market, critically assessing the lessons learned and insights for the future, from both the Humira and non-Humira biosimilar launches

Appreciating the impact of the Biden Administration’s cadence on drug prices on manufacturer pipelines, product launches, and pricing strategies

An updated decision matrix to assist in making the critical decision of venue selection – to dance, or not to dance?

Satisfying the data requirements for biosimilarity, interchangeability and compliant labelling

Spotlight on the litigation, regulatory and commercial strategies for innovators and biosimilars operating in China and emerging markets

And more!

CLE ACCREDITATION

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.