Abstract
Approval of the first biosimilar in the USA may occur by the end of 2014, yet a naming approach for biosimilars has not been determined. Biosimilars are highly similar to their biologic reference product but are not identical to it, because of their structural complexity and variations in manufacturing processes among companies. There is a need for a naming approach that can distinguish a biosimilar from its reference product and other biosimilars and ensure accurate tracing of adverse events (AEs) to the administered product. In contrast, generic small-molecule drugs are identical to their reference product and, therefore, share the same nonproprietary name. Clinical trials required to demonstrate biosimilarity for approval may not detect rare AEs or those occurring after prolonged use, and the incidence of such events may differ between a biosimilar and its reference product. The need for precise biologic identification is further underscored by the possibility of biosimilar interchangeability, a US designation that will allow substitution without prescriber intervention. For several biologics, the US Food and Drug Administration (FDA) has used a naming approach that adds a prefix to a common root nonproprietary name, enabling healthcare providers to distinguish between products, avoid medication errors, and facilitate pharmacovigilance. We recommend that the FDA implement a biosimilars naming policy that likewise would add a distinguishable prefix or suffix to the root nonproprietary name of the reference product. This approach would ensure that a biosimilar could be distinguished from its reference product and other biosimilars in patient records and pharmacovigilance databases/reports, facilitating accurate attribution of AEs.
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Acknowledgments
Nicole Casadevall has received research support from Amgen Inc., Roche, and Johnson & Johnson; has served as an advisor to Novartis and Shire; and has participated in lectures and/or boards sponsored by Amgen Inc., Johnson & Johnson, Shire, Novartis, and Roche. Thomas Felix is an employee of and owns stock in Amgen Inc. and has provided expert testimony in support of state bills for automatic substitution of interchangeable biosimilars. Bruce E. Strober has served on advisory boards for AbbVie, Amgen Inc., Janssen, Pfizer, Celgene, Novartis, and UCB Pharma; has served as a consultant to AbbVie, Amgen Inc., Janssen, Novartis, Pfizer, Celgene, Maruho, and Lilly; and has received honoraria for speakers’ bureau participation from AbbVie. David G. Warnock has received grants from Genzyme and Amgen Inc.; has participated in clinical research studies sponsored by Amicus; has served as a consultant to Amgen Inc., Genzyme, and Shire; and owns stock or stock options in Reata, Parion, Relypsa, and AlloCure.
The authors would like to thank James Balwit, MS, whose work was funded by Amgen Inc., for assistance in the preparation of this manuscript.
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Casadevall, N., Felix, T., Strober, B.E. et al. Similar Names for Similar Biologics. BioDrugs 28, 439–444 (2014). https://doi.org/10.1007/s40259-014-0099-9
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DOI: https://doi.org/10.1007/s40259-014-0099-9