Global Poster Presentations Convey Need for Distinct Biosimilar Names
July 5, 2016
Patient advocates have teamed up to take an important message to European physicians and policymakers: distinct names for biosimilar medications are essential. The Global Alliance for Patient Access and the Alliance for Safe Biologic Medicines recently presented posters at two European health policy meetings. The posters feature survey data from physicians to highlight the need for more education about how physicians can – and cannot – interpret nonproprietary drug names.
Reframing data from a 2013 online survey by the Alliance for Safe Biologic Medicines, the posters appeared at the European League Against Rheumatism’s annual congress in London and at the 20thInternational Congress of Parkinson’s Disease and Movement Disorders in Berlin. The posters depict feedback from physicians in the United States, France, Germany, Italy, Spain and the United Kingdom. These physicians represent a range of specialty areas, including neurology, nephrology, oncology, dermatology, rheumatology and endocrinology.
The study’s objective, the posters explain, was “to evaluate differences in physicians’ understanding of biologic and biosimilar medicines.” The results demonstrated that if two medicines have identicalnon-proprietary names, physicians tend to mistakenly assume that:
- They are structurally identical (U.S. 76%, Europe 53%)
- A patient can be switched between products during treatment and experience the same results (U.S. 76%, Europe 47%)
- A patient can receive and safely experience the same result with either product (U.S. 64%, Europe 39%).
These misunderstandings were most prevalent among physicians in the United States. Given the potential effect of these misunderstandings on patient health and clinical care, GAfPA and ASBM’s posters contend that distinct names are “essential” for reducing confusion and maximizing informed care decisions.
The World Health Organization has called for the use of biological qualifiers that create distinguishable names for biologics and biosimilars. In the United States, the Food and Drug Administration issued draft guidance calling for distinct non-proprietary names but has yet to determine whether the qualifiers will be memorable or randomly generated. Final FDA guidance on naming is forthcoming.
Tags: Biologics, Regulatory IssuesCategorized in: Blog