PMID- 25557261
OWN - NLM
STAT- MEDLINE
DCOM- 20150928
LR  - 20150219
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 14
IP  - 3
DP  - 2015 Mar
TI  - Active and passive surveillance of enoxaparin generics: a case study relevant to 
      biosimilars.
PG  - 349-60
LID - 10.1517/14740338.2015.1001364 [doi]
AB  - OBJECTIVE: This retrospective analysis assessed the capability of active and 
      passive safety surveillance systems to track product-specific safety events in 
      the USA for branded and generic enoxaparin, a complex injectable subject to 
      immune-related and other adverse events (AEs). METHODS: Analysis of 
      heparin-induced thrombocytopenia (HIT) incidence was performed on benefit claims 
      for commercial and Medicare supplemental-insured individuals newly treated with 
      enoxaparin under pharmacy benefit (1 January 2009 - 30 June 2012). Additionally, 
      spontaneous reports from the FDA AE Reporting System were reviewed to identify 
      incidence and attribution of enoxaparin-related reports to specific 
      manufacturers. RESULTS: Specific, dispensed products were identifiable from 
      National Drug Codes only in pharmacy-benefit databases, permitting sensitive 
      comparison of HIT incidence in nearly a third of patients treated with brand or 
      generic enoxaparin. After originator medicine's loss of exclusivity, only 5% of 
      spontaneous reports were processed by generic manufacturers; reports attributable 
      to specific generics were approximately ninefold lower than expected based on 
      market share. CONCLUSIONS: Claims data were useful for active surveillance of 
      enoxaparin generics dispensed under pharmacy benefits but not for products 
      administered under medical benefits. These findings suggest that the current 
      spontaneous reporting system will not distinguish product-specific safety signals 
      for products distributed by multiple manufacturers, including biosimilars.
FAU - Grampp, Gustavo
AU  - Grampp G
AD  - Amgen, Inc. , 4000 Nelson Rd, Longmont, CO 80503 , USA +1 303 401 2587 ; +1 303 
      401 4404 ; ginog@amgen.com.
FAU - Bonafede, Machaon
AU  - Bonafede M
FAU - Felix, Thomas
AU  - Felix T
FAU - Li, Edward
AU  - Li E
FAU - Malecki, Michael
AU  - Malecki M
FAU - Sprafka, J Michael
AU  - Sprafka JM
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150105
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Anticoagulants)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Drugs, Generic)
RN  - 0 (Enoxaparin)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Anticoagulants/administration & dosage/adverse effects
MH  - Biosimilar Pharmaceuticals/administration & dosage/*adverse effects
MH  - Drugs, Generic/administration & dosage/*adverse effects
MH  - Enoxaparin/administration & dosage/*adverse effects
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Product Surveillance, Postmarketing/methods
MH  - Retrospective Studies
MH  - Thrombocytopenia/*chemically induced/epidemiology
MH  - United States/epidemiology
OTO - NOTNLM
OT  - biosimilar
OT  - enoxaparin
OT  - pharmacovigilance
OT  - safety surveillance
EDAT- 2015/01/06 06:00
MHDA- 2015/09/29 06:00
CRDT- 2015/01/06 06:00
PHST- 2015/01/06 06:00 [entrez]
PHST- 2015/01/06 06:00 [pubmed]
PHST- 2015/09/29 06:00 [medline]
AID - 10.1517/14740338.2015.1001364 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2015 Mar;14(3):349-60. doi: 10.1517/14740338.2015.1001364. 
      Epub 2015 Jan 5.