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Health Care Stakeholders Urge FDA to List Meaningful Suffixes for Biosimilars
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The FDA received a letter from a 70-group coalition of health care stakeholders, including patients and provider organizations, urging the use of distinguishable, meaningful suffixes for biosimilars.
According to a press release, the letter stated that by instituting a distinguishable naming system that incorporates meaningful, memorable suffixes, the FDA would provide strong patient protections and critical transparency and promote pharmacovigilance, resulting in greater prescriber confidence. Patients, providers and pharmacists can easily recognize and remember meaningful suffixes, according to the release, which will facilitate an accurate association between adverse events and specific products.
The letter notes support for a distinguishable naming system from physicians and pharmacists, with 60% of 400 prescribers and 77% of 401 pharmacists surveyed indicating a preference for meaningful rather than random suffixes.
“There is no margin of error for patients who are managing serious and complex conditions,” Kathleen Arntsen, president and chief executive officer of the Lupus and Allied Diseases Association, said in the press release.
She added, “Precise prescribing and documentation of adverse events is absolutely a matter of life and death for individuals struggling to live with these diseases.”
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