FDA’s Move to Streamline Biosimilar Approval: What In-House Counsel Must Prepare For Now
On 29 Oct. 2025, FDA released a new draft guidance (on the need for demonstrating comparative clinical efficacy studies) signaling a major shift in biosimilar regulation. After more than a decade of experience reviewing biosimilar applications, the agency is now openly embracing a streamlined, analytics-first approval pathway; one that significantly reduces reliance on comparative clinical […]