Biosimilar Confidence And Knowledge Needed In Europe, Say Experts
European biosimilar market penetration varies widely across the EU member states and disease groups, with different government policies on promotion, purchasing and communication leading to mistrust. The European Commission is looking to boost confidence in biosimilars to support their uptake on a much wider scale across Europe, and to get a bird's eye view of what is driving or hindering the EU market for biosimilars.
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National pharmacovigilance center will pilot a national system for monitoring switches among innovator drugs and biosimilars.
After a 'slightly conservative approach' at the beginning, 'we are now getting to the meat of what we can do with biosimilars,' the European Medicine Association's Head of Quality Peter Richardson says.
The French regulatory agency ANSM has relaxed its stance on biosimilar interchangeability to state that while in principle patients should preferably not be switched between a reference drug and a biosimilar during their course of treatment, this can be done provided the patient agrees and their treatment is closely monitored1.