Biosimilars naming, label transparency and authority of choice – survey findings among European physicians
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 2
Abstract
Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The Alliance for Safe Biologic Medicines recruited 470 prescribers with clinical experience of biologicals in France, Germany, Italy, Spain and the UK to answer questions relating to their experience with these medicines in a 15-minute web-based survey which was carried out in the last quarter of 2013. Results: Of the physicians surveyed, 53% mistakenly felt that an identical non-proprietary name implies identical structure; 61% said that identical non-proprietary names imply that the medicines are approved for the same indications, which they may not be, and 24% said they recorded only the non-proprietary name of the biological product in the patient record. Conclusion: The responses of the European physicians demonstrate the need for distinguishable non-proprietary names to be given for all biologicals. Biosimilars, in contrast to generic drugs, have different structures, may have a different therapeutic profile, and may not be approved for all the indications for which the reference product has been approved.
Authors and Affiliations
Richard O Dolinar, Michael S Reilly
Keywords
Related Articles
- EP ID EP354360
- DOI 10.5639/gabij.2014.0302.018
- Views 105
- Downloads 0
Alternative statistical strategies for biosimilar drug development
Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar...
Weighing up the cost of switching to biosimilars
It is far from clear whether off-patent biological medicines can offer the same cost savings as those offered by off-patent non-biological (chemically derived) medicines, write a group of Brussels-based health economists...
Introduction to the GaBI Journal
I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal).
The ethics of biosimilars
Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars, published in GaBI Journal, 2012, issue 3-4.
What lessons can be learned from the launch of generic clopidogrel?
Introduction and study objectives: Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue...