title: Structural and pharmacological profile of generic enoxaparins used in Brazil.
abstract: Generic active pharmaceutical ingredients (APIs) have been commonly used in Brazil, since 1999, but most of them are synthetic and small molecules. Recently, a large number of generic enoxaparins were introduced into the market raising concerns related to product-to-product interchangeability, efficiency, and drug counterfeiting. These drugs are produced from biological sources and their production involves complex procedures and purification processes. The present article evaluates several generic enoxaparins, structurally and pharmacologically, and compares them with the branded products. Structural analysis showed that the generic products are, indeed, quite similar to the branded products, however, this similarity cannot be extended to their pharmacological activities. The results showed that generic products must go through extensive structural, pharmacological, and clinical evaluation in order to assess their quality, efficacy and, ultimately, avoid drug counterfeiting before clinical use. Variation was also observed between the branded products, showing that such drugs must be at constant surveillance.
authors.affiliation: Departamento de Bioquímica, Disciplina de Biologia Molecular, Universidade Federal de São Paulo, SP, Brazil.
authors.forename: Marcelo A
authors.initials: MA
authors.lastname: Lima
authors.forename: Eduardo H C
authors.initials: EH
authors.lastname: de Farias
authors.forename: Angel
authors.initials: A
authors.lastname: Gray
authors.forename: Nasir
authors.initials: N
authors.lastname: Sadeghi
authors.forename: Tarsis F
authors.initials: TF
authors.lastname: Gesteira
authors.forename: Renan P
authors.initials: RP
authors.lastname: Cavalheiro
authors.forename: Debra
authors.initials: D
authors.lastname: Hoppensteadt
authors.forename: Jawed
authors.initials: J
authors.lastname: Fareed
authors.forename: Guilherme L
authors.initials: GL
authors.lastname: Sassaki
authors.forename: Helena B
authors.initials: HB
authors.lastname: Nader
mesh_terms: D001938:Brazil; D016568:Drugs, Generic / Q000032:analysis* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D017984:Enoxaparin / Q000032:analysis* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male
chemical_list: D016568:Drugs, Generic; D017984:Enoxaparin