Biosimilar medicines clinical use: an experience based-EU perspective
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Biosimilar medicines clinical use: an experience based-EU perspective Adrian van den Hoven 13 July 2017 Washington D.C. ,USA
patients • quality • value • sustainability • partnership
Large Body of Confirmatory Evidence 11 Years of Biosimilar medicines Clinical Use Real-world experience
Controlled experience
700 million patient days1 “Over the last 10 years, the EU
monitoring system for safety concerns has not identified any difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicine” 2
1
Medicines for Europe information based on EMA Post-authorisation Safety Update Reports (PSURs) – European Commission: Biosimilars in the EU – Information guide for healthcare professionals, 2017 (link)
2 EMA
Biosimilar medicines increase patient access Change in # of treatment days (2016 vs. year before biosimilar entrance)
Epoetin
+66%
G-CSF (filgrastim)
+122%
Growth hormone (somatropin)
+41%
Anti-TNF (infliximab & etanercept)
+19%
Fertility (follitropin alfa)
+16%
Insulins
+19%
Source: QuintilesIMS (2017) The Impact of Biosimilar Competition in Europe
+228% UK
+163% Bulgaria
patients • quality • value • sustainability • partnership
References (1)
What you need to know about biosimilar medicinal products
What I need to know about biosimilar medicines – Information for patients
Biosimilars in the EU – Information guide for healthcare professionals
European Commission, 2013 (link)
European Commission, 2016 (link)
EMA, 2017 (link)
The impact of biosimilar competition in Europe QuintilesIMS, 2017 (link)
References (2) • Biosimilar regulation in the EU (link) Kurki & Ekman, Review of Clinical Pharmacology 2015
• The safety of switching between therapeutic proteins (link) Ebbers et al. Expert Opinion on Biological Therapy 2012
• In support of the European Union biosimilar framework (link) • Biosimilars: How can payers get long-term savings (link) Schneider et al, Nature Biotechnology 2012
• Biosimilars: what clinicians should now (link) Weise et al, Blood 2012
Mestre-Ferrandiz et al. PharmacoEconomics 2016
• Biosimilar infliximab In inflammatory bowel disease: Outcomes of a managed switching programme (link) Razanskaite et al. Journal of Crohn’s and Colitis 2017
• Is there a reason for concern or is it just hype? A systematic literature review of the clinical consequences • Delivering on the potential of biosimilar medicines (link) of switching from originator biologics to biosimilars (link) IMS Institute 2016 Inotai et al, Expert Opinion on Biological Therapy 2017
• Biosimilars: a position paper of the European Society for • Interchangeability of biosimilars: A European perspective Medical Oncology (ESMO), with particular reference to (link) oncology prescribers (link) Kurki et al. Biodrugs 2017
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