Biosimilars Market Access

Although the first biosimilar was approved by the FDA in March 2015, many questions regarding how these products should actually be brought to market remain. In addition to the commercial considerations around pricing and access, manufacturers are also keeping a watchful eye on the unsettled regulatory issues that still exist including guidance around the naming of the drugs, extrapolation of indications, and interchangeability.

The 2nd Annual Biosimilars Market Access Summit brings together a multi-stakeholder faculty to address the regulatory and commercial issues that manufacturers must address when looking to bring these products to market in the U.S.

Key Takeaways:

• Gain an update on the latest FDA guidances and thinking
• Understand the current market dynamics for biosimilar uptake in the U.S.
• Explore payer and provider considerations for market entry
• Examine various pricing strategies and other market access approaches
• Identify ways to encourage physician and patient acceptance of biosimilars

Featured Speakers Include

Molly Burich, MS Associate Director: Public Policy – Biosimilars, Pipeline and Reimbursement Boehringer Ingelheim Pharmaceuticals, Inc	Mary Jo Carden, RPh, JD Vice President of Government and Pharmacy Affairs Academy of Managed Care Pharmacy	Bernadette Eichelberger, PharmD Program Director Biologics and Biosimilars Collective Intelligence Consortium (BBCIC)
Sally Howard, JD Former Senior Advisor to the Commissioner, FDA; Head of Regulatory Affairs and Policy , Human Longevity, Inc.	Elizabeth Jex, Esq. Attorney Advisor, Office of Policy Planning FTC	Sue Naeyaert Senior Director Biosimilars Policy North America EMD Serono
Nicole Quon, Ph.D. Head, Global Payer Marketing & Market Development Biosimilars Boehringer Ingelheim GbmH	Alex Waldron Global Commercial Operations Epirus Pharmaceuticals