ArticleNature biotechnology2013
Scientific considerations in the review and approval of generic enoxaparin in the United States.
Article in Nature biotechnology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04402762 (Pharmacodynamic Equivalence of Ovine Enoxaparin to Porcine Enoxaparin), which is not on this map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pharmacodynamic Equivalence of Ovine Enoxaparin to Porcine Enoxaparin (Lovenox®) in Healthy Volunteers
Who cites it
24 citing papers in PubMed.
- Evaluation of Immunostimulatory Potential of Branded and US-Generic Enoxaparins in an In Vitro Human Immune System Model.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2015Trial
- Nano-anticoagulant based on carrier-free low molecular weight heparin and octadecylamine with an albumin shuttling effect.Nature communications · 2024Article
- Synthesis of bioengineered heparin chemically and biologically similar to porcine-derived products and convertible to low MW heparin.Proceedings of the National Academy of Sciences of the United States of America · 2024Article
- Rivaroxaban versus enoxaparin plus clopidogrel therapy for hypertrophic cardiomyopathy-associated thromboembolism in cats.Veterinary world · 2024Article
- Untoward immune effects of modern medication.Journal of biomedical research · 2023Article
- A Precise qNMR Method for the Rapid Quantification of Lot-to-Lot Variations in Multiple Quality Attributes of Pentosan Polysulfate Sodium.The AAPS journal · 2023Article
- Commercial Low Molecular Weight Heparins - Patent Ecosystem and Technology Paradigm for Quality Characterization.Journal of pharmaceutical innovation · 2022Article
- An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide.Molecules (Basel, Switzerland) · 2021Article
- Platelet factor 4 polyanion immune complexes: heparin induced thrombocytopenia and vaccine-induced immune thrombotic thrombocytopenia.Thrombosis journal · 2021Review
- Therapeutic strategies for thrombosis: new targets and approaches.Nature reviews. Drug discovery · 2020Review
- In-depth structural characterization of pentosan polysulfate sodium complex drug using orthogonal analytical tools.Carbohydrate polymers · 2020Article
- Heparanase as an Additional Tool for Detecting Structural Peculiarities of Heparin Oligosaccharides.Molecules (Basel, Switzerland) · 2019Article
- Salt-free fractionation of complex isomeric mixtures of glycosaminoglycan oligosaccharides compatible with ESI-MS and microarray analysis.Scientific reports · 2019Article
- Pharmaceutical "New Prior Knowledge": Twenty-First Century Assurance of Therapeutic Equivalence.AAPS PharmSciTech · 2019Article
- Comparative Pharmacokinetic Profile of 3 Batches of Ovine Low-Molecular-Weight Heparin and 1 Batch of Branded Enoxaparin.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2018Article
- The Botanical Drug Substance Crofelemer as a Model System for Comparative Characterization of Complex Mixture Drugs.Journal of pharmaceutical sciences · 2017Article
- Synthetic oligosaccharides can replace animal-sourced low-molecular weight heparins.Science translational medicine · 2017Article
- Modernization of Enoxaparin Molecular Weight Determination Using Homogeneous Standards.Pharmaceuticals (Basel, Switzerland) · 2017Article
- Combining measurements to estimate properties and characterization extent of complex biochemical mixtures; applications to Heparan Sulfate.Scientific reports · 2016Article
- Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.PloS one · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
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, equivalence in disaccharide building blocks, fragment mapping and sequence of oligosaccharide species; fourth, equivalence in biological and biochemical assays; and finally, equivalence of in vivo pharmacodynamic profile. In addition to fulfillment of these criteria, FDA also used in vitro, ex vivo and model animal data to ensure there was no increased immunogenicity risk of the generic enoxaparin product relative to the brand name product. The approval of the highly complex enoxaparin product using this framework under the ANDA pathway represents a major development. It also suggests that analytical and scientific advancements may in certain cases allow the elimination of unnecessary in vivo testing in animals and humans.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.