Evidence map›Paper›PMID 31378961›Full record

ReviewBritish journal of clinical pharmacology2019

Biosimilars of low molecular weight heparins: Relevant background information for your drug formulary.

Jacobus R B J Brouwers, Jeanine E Roeters van Lennep, Maarten J Beinema

Abstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Jacobus R B J BrouwersUnit Pharmacotherapy -Epidemiology and -Economy, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands.ORCID 0000-0002-7547-1662
Jeanine E Roeters van LennepDepartment of Internal Medicine-subdivision Vascular Medicine, Erasmus Medical Center Rotterdam, The Netherlands.
Maarten J BeinemaAnticoagualation Center, Deventer Hospital, Deventer, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biosimilars of low molecular weight heparins (LMWHs) are more alike the originator than different branded LMWHs. The latter differ largely in molecular weight, anti-FXa/anti-FIIa ratio and antithrombin binding. The Food and Drug Administration and European Medicines Agency guidelines are sufficient for the clinical use of high quality LMWHs. However, the Food and Drug Administration guideline lacks the results of a phase I clinical trial in the approval process. Most information about biosimilars is available for enoxaparin given that many biosimilars of enoxaparin have received market access. The guidelines of many International Thrombosis Societies for LMWH biosimilars are too stringent, not updated and impractical for formulary uptake discussions. This review gives background information on critical factors for the formulary uptake process of LMWHs with special attention for the use of the System of Objectified Judgment Analysis/Infomatrix model.

Indexed as

Practice Guidelines as TopicAnticoagulantsBiosimilar PharmaceuticalsDrug ApprovalEnoxaparinEuropeHumansThrombocytopeniaThrombosisUnited StatesUnited States Food and Drug AdministrationAnticoagulantsBiosimilar PharmaceuticalsEnoxaparinanticoagulantbiosimilarformularygenericslow molecular weight heparin

Identifiers

PMID31378961
PMCPMC6848910

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.