On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly.
The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western European countries: the United Kingdom, France, Germany, Italy, and Spain.
The responses demonstrated a need for further education about the nature of biosimilars, and underscored the need for biosimilars to have distinguishable nonproprietary names from their reference products.
Of the physicians surveyed, 53 percent mistakenly believed an identical nonproprietary name implies identical structure; and 61 percent said that identical nonproprietary names imply that the medicines are approved for the same indications, which may not be the case.
Additionally, 24 percent of respondents said they recorded only the nonproprietary name of the biological product in the patient record. Without unique nonproprietary names to distinguish biosimilars from their reference products, this could result in pooling of adverse events, misattribution, and other difficulties.
The survey was conducted in November of 2013, and its results were presented by ASBM to the World Health Organization as part of its 58th Consultation on International Nonproprietary Names in April.
View GaBI paper here.