Recurrent life-threatening deep tissue hematomas after switching to generic enoxaparin: A report and perspective on the approval process for biological compounds

Benjamin H. Kaffenberger, Tanios Bekaii-Saab

Research output: Contribution to journalReview article

Abstract

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.

Original languageEnglish (US)
Pages (from-to)104-106
Number of pages3
JournalClinical and Applied Thrombosis/Hemostasis
Volume18
Issue number1
DOIs
StatePublished - Jan 1 2012
Externally publishedYes

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Keywords

  • anticoagulants
  • bleeding
  • heparins
  • low-molecular-weight heparins

ASJC Scopus subject areas

  • Hematology

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