🌟 Insights from Day 2 of last week’s Biosimilar Medicines Conference in Amsterdam!
Last Friday’s sessions highlighted key updates from global regulators, including the FDA, European Medicines Agency, ANVISA in Brazil and the Medicines and Healthcare products Regulatory Agency. Discussions have shifted away from the need for confirmatory efficacy studies to focus on comprehensive physicochemical and biological characterization and pivotal comparative PK studies.
This shift towards reducing the need for clinical efficacy studies represents a potentially significant breakthrough. In addition, forthcoming FDA updates aim to refine guidance on biosimilar interchangeability at the pharmacy level to ensure that all approved biosimilars are interchangeable. Furthermore, a major meta-analysis has shown that there is no risk associated with switching from reference products to biosimilars, underscoring their safety.
🌟 Despite progress in regulatory pathways, significant challenges remain in terms of access and uptake in different countries. Significant progress has been made, but the journey continues and there is still much to be done.
