TY - JOUR
T1 - Recurrent life-threatening deep tissue hematomas after switching to generic enoxaparin
T2 - A report and perspective on the approval process for biological compounds
AU - Kaffenberger, Benjamin H.
AU - Bekaii-Saab, Tanios
PY - 2012/1
Y1 - 2012/1
N2 - In the United States, the Food and Drug Administration (FDA) has allowed makers of biologic therapies to use the abbreviated new drug application, which does not require safety and efficacy studies. Instead this relies on proving equivalency with the original compound and demonstrating in vitro activity and similar pharmacodynamics. In the United States, a low-molecular-weight heparin, enoxaparin, was recently approved in a generic format through the abbreviated new drug application. We present a patient treated with branded enoxaparin for 4 years with no complications. After the switch to the generic enoxaparin, the patient developed 2 life-threatening hemorrhages within 4 months of the initiation of the compound. This case suggests that the FDA should follow the European Medicine Administration (EMA) guidance by tightening its approval process for generic bioequivalents and requiring studies demonstrating similar safety and efficacy as the parent compound, prior to approval of a generic biologically active compound.
AB - In the United States, the Food and Drug Administration (FDA) has allowed makers of biologic therapies to use the abbreviated new drug application, which does not require safety and efficacy studies. Instead this relies on proving equivalency with the original compound and demonstrating in vitro activity and similar pharmacodynamics. In the United States, a low-molecular-weight heparin, enoxaparin, was recently approved in a generic format through the abbreviated new drug application. We present a patient treated with branded enoxaparin for 4 years with no complications. After the switch to the generic enoxaparin, the patient developed 2 life-threatening hemorrhages within 4 months of the initiation of the compound. This case suggests that the FDA should follow the European Medicine Administration (EMA) guidance by tightening its approval process for generic bioequivalents and requiring studies demonstrating similar safety and efficacy as the parent compound, prior to approval of a generic biologically active compound.
KW - anticoagulants
KW - bleeding
KW - heparins
KW - low-molecular-weight heparins
UR - http://www.scopus.com/inward/record.url?scp=84857554998&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84857554998&partnerID=8YFLogxK
U2 - 10.1177/1076029611416641
DO - 10.1177/1076029611416641
M3 - Review article
C2 - 21873360
AN - SCOPUS:84857554998
SN - 1076-0296
VL - 18
SP - 104
EP - 106
JO - Clinical and Applied Thrombosis/Hemostasis
JF - Clinical and Applied Thrombosis/Hemostasis
IS - 1
ER -