The World Health Organization recently published the Executive Summary of its 73rd Consultation on International Nonproprietary Names, at which ASBM presented on October 19, 2021.
From the Executive Summary:
Objections to the use of distinct non-proprietary names for biosimilars quote that they may imply inferiority, that they may undermine confidence in their use and may hinder uptake. However, in the USA where biologics and biosimilars are distinguished with 4-letter suffix, this is not the case. In a new ASBM survey of 403 physicians who prescribe biologics in practice, a good majority did not think the FDA suffix implies inferiority while >90% expressed confidence in the safety and efficacy of biosimilars.
Notably, US physicians were more comfortable prescribing biosimilars to naïve patients than their EU counterparts. It is important to note also that in the USA all biosimilars and reference products will eventually have suffixes in the product name.
As to whether the FDA suffixes had held back adoption of biosimilars, it was shown that filgrastim biosimilars had achieved an 80% share of the market, and that various MAb biosimilars have a good share of the US market and which is expected to be >50% within 2 years, with price and not nomenclature appearing to be the predominant factor in increasing biosimilar uptake.
In summary, the ASBM concluded that even in advanced countries there is inadequate identification using the brand name only and using distinguishable non-proprietary naming will strengthen pharmacovigilance programmes. A concern that distinguishable naming via use of a suffix would imply inferiority and hurt uptake, does not appear to be borne out and the ASBM will continue to work with regulators on this issue.
…The Chair noted that there was a perception in some circles that the INN Programme’s BQ proposal was closed, whereas essentially it is on hold, and requested the ASBM to continue the debate not only with the INN group but also to write to the Executive Board of the WHO.
Read the full Executive Summary here.
