2013
DOI: 10.1038/nbt.2528
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Scientific considerations in the review and approval of generic enoxaparin in the United States

Abstract: In 2010, the US Food and Drug Administration (FDA) approved a generic low-molecular-weight heparin without clinical safety or efficacy data under the Abbreviated New Drug Application (ANDA) pathway. To enable a determination of active ingredient sameness of generic and innovator enoxaparin products, the FDA developed a scientifically rigorous approach based on five criteria: first, equivalence of physicochemical properties; second, equivalence of heparin source material and mode of depolymerization; third, equ… Show more

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Cited by 69 publications
(36 citation statements)
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“…Only a fraction of oligosaccharides in LMWH exhibit anticoagulant activity. The structural heterogeneity in LMWHs results in batch-to-batch differences in saccharide composition and sequence and anticoagulant activity (6). …”
Section: Introductionmentioning
confidence: 99%
“…Only a fraction of oligosaccharides in LMWH exhibit anticoagulant activity. The structural heterogeneity in LMWHs results in batch-to-batch differences in saccharide composition and sequence and anticoagulant activity (6). …”
Section: Introductionmentioning
confidence: 99%
“…Chemoenzymatic synthesis offers a promising approach toward this goal. A homogeneous product reduces the complexity for the quality control during the manufacturing process and is compatible with standard approval processes by regulatory agencies 24 . Although the structures produced through chemoenzymatic synthesis are limited by the substrate specificities of the enzymes, their synthetic capability can be expanded through better understanding of enzyme properties.…”
mentioning
confidence: 99%
“…18 Specific glycosylation patterns (i.e., the composition of attached sugar moieties) of antibodies can also be used as an indicator of a consistent manufacturing process or to identify the effect that changes to the manufacturing process have on the molecule. 19,20 Characterized by the degree of galactose sugar molecules, one of the major glycoforms of mAbs, including adalimumab, is the agalactosyl fucosylated biantennary oligosaccharide (G0F) species that contains fucose but no terminal galactosylation. 21 Evidence that glycosylation patterns affect protein function is accumulating, and differential glycosylation has been shown to influence serum clearance in human studies of therapeutic antibodies with oligomannose sugars, [21][22][23] antibodydependent cell-mediated cytotoxicity or complement-dependent cytotoxicity, 18,21,24 and serum half-life due to differences in binding to the Fc receptors.…”
Section: Humiramentioning
confidence: 99%