Factors that may account for the slow development of the market for biosimilars in the US are discussed by Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA [1]. In this article, the factor of biosimilars naming is discussed.
In contrast to small molecule generics, which physicians are comfortable prescribing, biosimilars are complex biological products. Therefore, even those who routinely use biologicals do not have a clear understanding of biosimilars. This hesitation is not improved by the fact that regulations create the impression that a biosimilar may not be all that similar to its originator.
Dr Frank points to the US Food and Drug Administration (FDA) guidance on naming of biologicals and biosimilars as being one such example. The agency issued final guidance on naming in January 2017 [2]. The guidance requires that each product include the non-proprietary name reflecting the active ingredient plus a meaningless suffix. One concern is that such naming creates the impression that the clinical effects of a biosimilar may differ meaningfully from the reference product.
FDA has defended its naming policy as necessary for pharmacovigilance of all biologicals [3]. However, groups, such as the International Generic and Biosimilar Medicines Association (IGBA), which represents generics and biosimilars makers across the globe, have called for biosimilars to share the same international non-proprietary name (INN) or proper name with the reference biological. The IGBA points to the fact that Europe has almost 10 years of safe clinical experience with biosimilars bearing the same INN as their respective reference biological [4].
The Generic Pharmaceutical Association (GPhA), has also said that the guidance had the potential ‘to erect barriers to patient access to new, more affordable medicines, and jeopardize their safety’ [5]. While the Academy of Managed Care Pharmacy (AMCP) has also said that ‘any departure from the currently accepted non-proprietary naming system will create confusion amongst healthcare practitioners and patients, have negative effects on the ability to ensure safe dispensing and tracking, and result in lower market adoption and cost-savings’ [6].
Healthcare organizations have also expressed their ‘grave concerns’ over the ‘enormous financial consequences’ of implementing FDA’s biologicals naming guidance. They say implementation will require updating existing electronic health record, billing and pharmacy systems and databases, as well as prescribing systems and millions of patient records and have asked the agency ‘to suspend implementation of the guidance until the exact economic impact can be determined, and less costly alternatives given full consideration’ [7].
Despite these concerns, the agency rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same non-proprietary names as their reference products in February 2017 [3].
Conflict of interest
Disclosure forms provided by the author [1] are available at NEJM.org.
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References
1. Frank RG. Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378(9):791-3.
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. FDA rejects petitions over biologicals naming guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Guidelines/FDA-rejects-petitions-over-biologicals-naming-guideline
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar naming in the US, the debate continues [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-naming-in-the-US-the-debate-continues
5. GaBI Online - Generics and Biosimilars Initiative. Arguments for same INN for biosimilars presented at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Biosimilars/General/Arguments-for-same-INN-for-biosimilars-presented-at-WHO-meeting
6. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
7. GaBI Online - Generics and Biosimilars Initiative. FDA biologicals naming guidance could cost providers billions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Biosimilars/General/FDA-biologicals-naming-guidance-could-cost-providers-billions
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