Translating European regulatory approval into healthcare uptake for biosimilars: the second translational gap

ABSTRACT

With 15 biosimilar molecules in 9 different molecular classes and currently marketed under 23 distinct brands, the European pathway for regulatory approval of biosimilars has been demonstrably tried and tested. The gap that now remains is the translation from regulatory assessment and approval to incorporation of biosimilars within our healthcare systems in Europe. Despite many efforts by regulators to reach out to clinicians, there remains a translational gap for biosimilars which need to be incorporated in healthcare pathways and understood by clinicians and patients. Only by bridging this gap will biosimilars fully play their role in healthcare for Europe.