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2017 ; 9
(6
): 898-906
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Changes to International Nonproprietary Names for antibody therapeutics 2017 and
beyond: of mice, men and more
#MMPMID28621572
Parren PWHI
; Carter PJ
; Plückthun A
MAbs
2017[Aug]; 9
(6
): 898-906
PMID28621572
show ga
Active pharmaceutical substances require an International Nonproprietary Name
(INN) assigned by the World Health Organization (WHO) to obtain market
authorization as a medicinal product. INNs are selected to represent a unique,
generic name for a drug enabling unambiguous identification by stakeholders
worldwide. INNs may be requested after initiating clinical development of an
investigational drug. Pharmaceutical classes are indicated by a common stem or
suffix. Currently, INNs for monoclonal antibody-based drugs are recognized by the
suffix, -mab, preceded by a source infix such as -xi- (chimeric), -zu-
(humanized) or -u- (human) designating the species from which the antibody was
derived. However, many technological advances have made it increasingly difficult
to accurately capture an antibody's source in its name. In 2014, the WHO and the
United States Adopted Names (USAN) Council approached this challenge by
implementing changes to antibody source infix definitions. Unfortunately, gaps
and ambiguities in the definitions and procedures resulted in inconsistent source
category assignments and widespread confusion. The Antibody Society, extensively
supported by academic and industry scientists, voiced concerns leading to
constructive dialog during scheduled consultations with WHO and USAN Council
representatives. In June 2017, the WHO announced that use of the source infix
will be discontinued for new antibody INNs effective immediately. We fully
support this change as it better aligns antibody INNs with current and
foreseeable future innovations in antibody therapeutics. Here we review the
changes implemented. Additionally, we analyzed antibody INNs recently assigned
under the previous 2014 definitions and provide recommendations for further
alignment.
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