Insights
20 October 2026
|6 min read
The EMA’s reflection paper on a tailored clinical approach to biosimilar development signals an important shift in how biosimilarity may be demonstrated. As analytical characterisation and pharmacokinetic studies become increasingly robust, comparative efficacy studies may not always provide additional value. This article explores the scientific rationale behind this evolving approach, the importance of structure-function relationships and residual uncertainty, and what these changes could mean for more streamlined, data-driven biosimilar development.
Insights
8 October 2026
|10 min read
How to assess cytokine release and immunogenicity risk in vitro before first-in-human dosing, which ADA assays are needed and what the guidance says.
Insights
30 September 2026
|12 min read
What in vitro pharmacology data do you need for a biologic IND filing? A practical guide to mechanism of action, potency, species relevance, immune safety and ICH S6(R1).
Insights
4 September 2026
|7 min read
RoukenBio’s human donor-derived air-liquid interface (ALI) asthma model recreates key features of Type 2 airway inflammation, including mucus production and epithelial remodelling. Discover how this translational platform supports target validation, biomarker analysis and therapeutic evaluation in asthma drug discovery.
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