The FDA announced the release of its draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” The document reflects the agency’s evolving perspective that modern analytical techniques often provide greater sensitivity in detecting differences between biosimilar candidates and their reference products than traditional comparative clinical studies focused on efficacy endpoints.
Since the original scientific considerations guidance was published in 2015, the FDA has gained substantial experience in assessing biosimilars, noting that many differences can be identified and evaluated through advanced analytical methods. As a result, the agency’s latest draft guidance offers an overview of key scientific factors to consider when deciding if a comparative efficacy study is necessary to establish biosimilarity.
The FDA states that this approach is intended to streamline the biosimilar development process, potentially reducing the time and financial burden on developers, and thereby increasing access to lower-cost biologic medicines for U.S. patients. The draft guidance is open for public comment via docket FDA-2011-D-0605, with instructions available on Regulations.gov.
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