Summary
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 States, 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. We’ve reached an inflection point in the United States. With another major wave of loss of exclusivities of original biological medicines expected in the next five to ten years, it is imperative that industry is well prepared today. 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. This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics. Goodwin is sponsoring this event and Huiya Wu will be a featured speaker on the panel titled “Global Strategies: From Patent Protection to Cost and Market Access.”
