PMID- 25001080
OWN - NLM
STAT- MEDLINE
DCOM- 20150609
LR  - 20160909
IS  - 1179-190X (Electronic)
IS  - 1173-8804 (Linking)
VI  - 28
IP  - 5
DP  - 2014 Oct
TI  - Similar names for similar biologics.
PG  - 439-44
LID - 10.1007/s40259-014-0099-9 [doi]
AB  - Approval of the first biosimilar in the USA may occur by the end of 2014, yet a 
      naming approach for biosimilars has not been determined. Biosimilars are highly 
      similar to their biologic reference product but are not identical to it, because 
      of their structural complexity and variations in manufacturing processes among 
      companies. There is a need for a naming approach that can distinguish a 
      biosimilar from its reference product and other biosimilars and ensure accurate 
      tracing of adverse events (AEs) to the administered product. In contrast, generic 
      small-molecule drugs are identical to their reference product and, therefore, 
      share the same nonproprietary name. Clinical trials required to demonstrate 
      biosimilarity for approval may not detect rare AEs or those occurring after 
      prolonged use, and the incidence of such events may differ between a biosimilar 
      and its reference product. The need for precise biologic identification is 
      further underscored by the possibility of biosimilar interchangeability, a US 
      designation that will allow substitution without prescriber intervention. For 
      several biologics, the US Food and Drug Administration (FDA) has used a naming 
      approach that adds a prefix to a common root nonproprietary name, enabling 
      healthcare providers to distinguish between products, avoid medication errors, 
      and facilitate pharmacovigilance. We recommend that the FDA implement a 
      biosimilars naming policy that likewise would add a distinguishable prefix or 
      suffix to the root nonproprietary name of the reference product. This approach 
      would ensure that a biosimilar could be distinguished from its reference product 
      and other biosimilars in patient records and pharmacovigilance databases/reports, 
      facilitating accurate attribution of AEs.
FAU - Casadevall, Nicole
AU  - Casadevall N
AD  - Hopital Saint Antoine, Paris, France.
FAU - Felix, Thomas
AU  - Felix T
FAU - Strober, Bruce E
AU  - Strober BE
FAU - Warnock, David G
AU  - Warnock DG
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - BioDrugs
JT  - BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
JID - 9705305
RN  - 0 (Biosimilar Pharmaceuticals)
SB  - IM
MH  - *Biosimilar Pharmaceuticals
MH  - Drug Approval/*organization & administration
MH  - Drug Substitution
MH  - Humans
MH  - Pharmacovigilance
MH  - *Terminology as Topic
MH  - United States
MH  - United States Food and Drug Administration/*organization & 
      administration/standards
EDAT- 2014/07/09 06:00
MHDA- 2015/06/10 06:00
CRDT- 2014/07/09 06:00
PHST- 2014/07/09 06:00 [entrez]
PHST- 2014/07/09 06:00 [pubmed]
PHST- 2015/06/10 06:00 [medline]
AID - 10.1007/s40259-014-0099-9 [doi]
PST - ppublish
SO  - BioDrugs. 2014 Oct;28(5):439-44. doi: 10.1007/s40259-014-0099-9.