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 106
- Downloads 0
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