On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development. The reflection paper considers the need for current comparability studies, including Comparative Efficacy Studies (“CES”). The reflection paper outlines various circumstances in which the other studies submitted as part of the Quality and Clinical sections may be sufficient to demonstrate biosimilarity either without the need for additional CES or with limited CES. However, the reflection paper also acknowledges various circumstances (such as if batches of the biosimilar candidate fail to meet the similarity criteria for biological activity) where CES may still be required. While not a policy change, the reflection paper concludes that “biosimilars may be approved without providing CES or even PD data if similar clinical efficacy and safety pharmacology can be inferred from a sufficiently stringent evaluation of analytical comparability, in vitro pharmacology, and a comparative clinical PK trial.” However, the reflection paper also acknowledges that whether a clinical program can forgo the CES requirement will depend on its similarity assessment. It also states that a well-defined comparative human PK study will still be required. The consultation period ends September 30, 2025.
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