Biosimilars Conference

The Biologics Price Competition and Innovation Act was signed into law on March 23, 2010 creating an abbreviated approval pathway for biosimilar medicines. The first biosimilar was approved in the US in 2015. As of today, FDA has approved 26 biosimilars and 17 have launched into the US market. As we analyze how the market has developed over the last 10 years, it is important to understand the progression of the market and answer an important question: What does success look like for the biosimilars in the U.S.? We will discuss the following:

• What are the metrics of success?
• Does the measure of success differ between product types, sites of care, disease states, & stakeholder groups?
• What is the vision of success that is or is not being met today?
• What is the U.S.’ definition of biosimilar market “equilibrium”? (i.e., the balance between success and failure)
• In what ways are biosimilars addressing health disparities and access to care, and should this factor into the evaluation of success?
• How are biosimilars laying the groundwork for the appropriate amount of reinvestment in innovation?