Biosimilar Naming: How Do Adverse Event Reporting Data Support the Need for Distinct Nonproprietary Names
for Biosimilars, The Food and Drug Law Institute, Vol.
NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, said at the World Health Organization (WHO) in Geneva, Switzerland, today that it is essential for biosimilar drugs to be given the same nonproprietary names
as original biologics to ensure that patients receive the full benefit of greater access and lower costs that these medicines can bring.
57) Outside of the United States, the World Health Organization (WHO) assigns drugs' nonproprietary names
--the International Nonproprietary Names
Food and Drug Administration (FDA) asking the agency to require biosimilars to bear nonproprietary names
that are similar to, but not the same as, those of their reference products or of other biosimilars.
Arranged alphabetically from acacia to zinc stearate, each entry is described in terms of 22 topics, among them: nonproprietary names
, synonyms, chemical name and CAS registry number, empirical formula and molecular weight and structural formula, functional category, supplications, physical appearance, pharmacopeial specifications, typical properties, stability and storage, incompatibilities, manufacture, safety, handling precautions, regulatory status, and related substances.
Composition: A detailed listing all chemical ingredients in generic or International Nonproprietary Names
together with their concentration or percentage; and
The RxNorm standard clinical drug vocabulary produced by the National Library of Medicine (NLM) now contains more accurate and complete connections between National Drug Codes (NDCs) and standard nonproprietary names
of medications recommended for use in electronic health records (EHRs).
Each monograph includes information on nonproprietary names
, synonyms, chemical name and Chemical Abstracts Service registry number, empirical formula and molecular weight, structural formula, functional category, applications in pharmaceutical formulation or technology, description, pharmacopoeial specifications, typical properties, stability and storage conditions, incompatibilities, method of manufacture, safety, handling precautions, regulatory status, related substances, specific and general references, and date of revision.
Finally, the Report presents a comprehensive review of International Nonproprietary Names
(INN) for Biological and Biotechnological Substances, which is likely to be of interest to all those dealing with health products.
The USAN Council serves health professions of the United States by selecting simple, informative and unique nonproprietary names
for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.
In closing, we restate our support for FDA's requirement that all biological products bear a distinguishable four-letter suffix to their nonproprietary names
and we urge the agency to ensure that the manufacturer is identified through the suffix.
Baxter, a pharmacist in the UK, presents about 1900 monographs for drugs or drug groups organized in alphabetical order by International Nonproprietary Names
, drawing from clinical studies, case reports, and systematic reviews and including ratings on the clinical significance of the interaction in terms of action, severity, and evidence.