EMA just released a draft " Reflection paper on a tailored clinical approach in biosimilar development". There have been many discussion on what is needed to prove the safety, efficacy and equivalency of biosimilars. This Reflection paper is taking up that discussion and considering all the factors broadly. From the Introduction:
"This reflection paper will examine settings for biosimilars where similar clinical efficacy and safety can be inferred from a conclusion of physicochemical and biological similarity and comparable pharmacokinetics. Currently, Comparative Efficacy Studies (CES) (in which safety and immunogenicity data are also routinely captured) can already be waived in case an accepted pharmacodynamic (PD) surrogate endpoint exists, but even this prerequisite might not be needed.
A further driver for this Reflection paper is the regulatory experience indicating that the results from the CES in the past generally did not add relevant additional information to the biosimilarity exercise (Guillen et al., Kirsch-Stefan et al., Bielsky MC et al., IPRP workshop report 2024).
In addition, trends are observed regarding the types of biological medicinal products losing market exclusivity, where feasibility of performing comparative efficacy trials appears limited. This is firstly due to originator products having narrow indications with small number of patients as well as originator products being used in increasingly complex add-on therapy settings.
Taken together, a regulatory option that, under certain prerequisites, allows authorisation based on demonstrated comparability at the quality level with a limited (tailored) clinical data package (based on a comparative PK trial) would provide a viable path forward for approving biosimilars with less clinical data.
Based on the points outlined above, a tailored approach for clinical development of biosimilar candidates can be envisioned. In certain cases, CES may no longer be required for approval of biosimilars that can be thoroughly characterised and have shown high similarity on an analytical and in vitro pharmacology level. Comparative clinical pharmacokinetic studies are still essential elements in biosimilar development but some adjustments to the data requirements, such as inclusion of immunogenicity parameters and/or modifying the study design (e.g., one-dose vs multiple-dose), could be considered."
https://www.ema.europa.eu/en/documents/other/reflection-paper-tailored-clinical-approach-biosimilar-development_en.pdf
#EMA #Biosimilars
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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