To the Editor
The mischaracterization of biologic naming policies in your December editorial1 is both surprising and disappointing. Biologic naming policies have longstanding scientific basis and are an important topic that deserves balanced consideration where they are discussed and reviewed. Amgen (Thousand Oaks, CA), as both a biologics innovator and a biosimilars developer, endorses distinguishable names for biosimilars as a means of manufacturer accountability.
Currently, there is a shortfall in companies following the existing World Health Organization (WHO; Geneva, Switzerland) International Nonproprietary Name (INN) rules for glycosylated proteins. With the single exception of epoetin zeta, mentioned in the editorial, biosimilars on the market in Europe have not followed WHO INN rules. In response to this breakdown of the existing INN system, the WHO is actively considering a mechanism for distinguishable nonproprietary identification of all biologics, not just biosimilars. The approach under discussion would not change the INN naming policies but would include the use of an identifier to help product-level traceability on a global level2.
Experience in other countries with distinguishable names for biosimilars supports this policy. Japan and Australia have adopted distinguishable names for biosimilars, and biosimilars continue to be a viable and important option for patients and physicians. Additionally, in a recent survey, 80% of US and European Union (EU; Brussels) physicians surveyed want distinguishable or unique names for biologics3.
Amgen is seeking distinguishable nonproprietary names for our biosimilar products and supports the use of an identifier for all of our biologic medicines. Simply put, distinguishable nonproprietary names are an easily implemented and reliable means of advancing accurate product identification. We share this perspective with many in our industry4.
Importantly, this simple measure could help increase confidence in biosimilars and support their continued success in Europe5 as well as providing consumer confidence when they are introduced in the United States.
References
Anonymous. Nat. Biotechnol. 31, 1055 (2013).
World Health Organization. 55th Consultation on International Nonproprietary Names for Pharmaceutical Substances (Geneva, 16–18 October 2012) http://www.who.int/medicines/services/inn/55th_Executive_Summary.pdf (INN Working Document 13.329) (WHO, 2013).
BioTrends Research Group, Biosimilars Advisory Service 2013. Acceptance of Biosimilars Across Physician Specialties (BioTrends Research Group, Exton, Pennsylvania, USA, 2013).
Acha, G. Getting the name right. Global Health Matters http://globalhealthmatters.ifpma.org/?s=getting+the+name+right (IFPMA, 5 November 2013).
Competitiveness in Healthcare Industries http://www.ec.europa.eu/enterprise/sectors/healthcare/competitiveness/index_en.htm (European Commission Enterprise and Industry Directorate-General in the Healthcare Industries, updated 4 February 2013).
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Geoff Eich is an employee of Amgen.
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Eich, G. A divided INN crowd. Nat Biotechnol 32, 131 (2014). https://doi.org/10.1038/nbt.2817
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DOI: https://doi.org/10.1038/nbt.2817