Horizon scan of the clinical development landscape of biosimilar products in the UK and EU
Abstract
Objectives: Biosimilars are biological medicines highly similar to an authorized reference medicine, offering substantial cost savings and increased treatment access. Despite the regulatory framework in the UK and EU facilitating their approval, the biosimilar landscape remains small compared to small-molecule drugs. This study provides a horizon scanning overview of the current biosimilar landscape, procured through horizon scanning activities.
Methods: Data were sourced from ClinicalTrials.gov and the EU Clinical Trials Register, scanned monthly to identify innovative medicines in clinical development. We included biosimilars identified through horizon scanning from April 2017 to February 2025. Supplementary data were collected from the European Medicines Agency to ascertain approval status, and additional clinical trial information was manually extracted from relevant registries.
Results: We identified 156 unique biosimilars developed across 174 clinical trials, with sixty-four approved by the MHRA and seventy-eight by the European Medicines Agency. Adalimumab, bevacizumab, and denosumab were the reference products with the most biosimilars in development. Most biosimilar trials were at phase III. There are seventy-one biosimilars in active development.
Conclusions: The development landscape of biosimilars in the UK and EU show high activity levels. Continuous improvements in horizon scanning methods and regulatory frameworks are essential to support the timely adoption…
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