Terminology for biosimilars–a confusing minefield

Thorpe, Robin

doi:10.5639/gabij.2012.0103-4.023

Cited by 16 publications

(12 citation statements)

References 11 publications

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“…There is a clear need for distinguishable non-proprietary names to be given to all biological medicines to ensure intended prescribing as well as to support product identifi cation when reporting and tracing adverse events [6][7][8].…”

Section: Resultsmentioning

confidence: 99%

Biosimilars naming, label transparency and authority of choice – survey findings among European physicians

Dolinar¹,

Reilly²

2014

GaBI J

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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 diff erent structures, may have a diff erent therapeutic profi le, and may not be approved for all the indications for which the reference product has been approved.

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Section: Resultsmentioning

confidence: 99%

Biosimilars naming, label transparency and authority of choice – survey findings among European physicians

Dolinar¹,

Reilly²

2014

GaBI J

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“…'A biosimilar is a copy version of an already authorized biological medicinal product with demonstrated similarity in physicochemical characteristics, effi cacy and safety, based on a comprehensive comparability exercise' [4].…”

Section: 'Similar Biologics' Approved and Marketed In Indiamentioning

confidence: 99%

‘Similar biologics’ approved and marketed in India

Editor¹

2013

GaBI J

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There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1]

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“…In other words, a biosimilar is a version of a previously approved biological medicine termed the reference product. Several names are given to biosimilars in different parts of the world, such as biocomparables, biological products, 'follow-on biologics', follow-on protein products, or subsequent entry biologicals [1,[6][7][8].…”

Section: Introductionmentioning

confidence: 99%