Amgen Supports Distinguishable Naming Policy for Biosimilars

The mischaracterization of biologic naming policies in the Nature Biotechnology editorial The INN Crowd is both surprising and disappointing.  Biologic naming policies have longstanding scientific basis and are important topics that deserve balanced consideration where they are discussed and reviewed. Amgen, as both a biologics innovator and a biosimilars developer, endorses distinguishable names as a means of manufacturer accountability.

Currently there is a shortfall in companies following the existing World Health Organization (WHO) International Non-proprietary 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 level.i

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.ii Additionally, in a recent survey, 80 percent of U.S. and EU physicians surveyed want distinguishable or unique names for biologics.iii

Amgen is seeking distinguishable non-proprietary names for our biosimilar products and supports the use of an identifier for all of our biologic medicines. Simply put, distinguishable non-proprietary names are an easily implemented and reliable means of advancing accurate product identification. We share this perspective with many in our industry.iv

Importantly, this simple measure could help increase confidence in biosimilars and support their continued success in Europev, as well as providing consumer confidence when they are introduced in the U.S.


  2. EvaluatePharma, accessed 11/21/13; Amgen analysis based on IMS data
  3. BioTrends Research Group, Biosimilars Advisory Service 2013: Acceptance of Biosimilars Across Physician Specialties