Regulatory and Clinical Considerations for Biosimilarity

Eighteen biosimilars were approved by the FDA through the 351(k) pathway as of the end of March 2019, but the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry's growing interest in developing biosimilars, it's critical that sponsors have a clear understanding of key clinical issues and develop a strategy for navigating today's regulatory environment.