Walking the Biosimilar Guideline

Biosimilars have been available in Europe for more than a decade and during this time the European Medicines Agency’s (EMA’s) original 2005 biosimilars guidelines have been regularly updated. Although many papers have been published describing how the regulations have changed over time, few have focused on how these regulations are applied in practice. For example, do all successful applications follow the guidelines exactly or are there instances where regulators are more flexible? Bernd Jilma, Professor of Clinical Pharmacology, and his colleagues at the Medical University of Vienna, carried out a systematic comparison of all clinical development programs that were approved by the EMA (1). The research was part of an IDEAS project – a European training network for early-stage researchers working on statistical methods for early drug development – and funded by the European Union’s Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant agreement. The researchers found that companies go about demonstrating biosimilarity in many different ways, with some even deviating from the guidelines but still receiving approval. We asked Jilma to tell us more.

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