Evidence map›Paper›PMID 27885553›Full record

SynthesisBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2016

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.

Ira Jacobs, Danielle Petersel, Leah Isakov, Sadiq Lula, K Lea Sewell

Open access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% of its field
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
    Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC).Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2018
    Article
  11. Article
  12. Article
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

5 authors at 1 institution in 1 country.

Ira JacobsPfizer Essential Health, Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA. ira.jacobs@pfizer.com.
Danielle PeterselPfizer Essential Health, Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA.
Leah IsakovPfizer Essential Health, Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA.
Sadiq LulaEnvision Pharma Group, London, UK.
K Lea SewellPfizer Essential Health, Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA.
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications.

objectivesThe objective of this study was to systematically collate all published data in order to assess the weight (quantity and quality) of available evidence for each molecule and inform and support healthcare decision-making in chronic inflammatory diseases.

methodsMEDLINE

resultsProposed biosimilars for adalimumab, etanercept, infliximab, and rituximab are reported in the published literature. Across indications, approved biosimilars infliximab CT-P13, SB2, and etanercept SB4 have published studies involving the largest number of patients or healthy subjects (n = 1405, 743, and 734, respectively), mostly in rheumatoid arthritis. At data cut-off, only CT-P13 had published data in ankylosing spondylitis (n = 250; randomized control trial) and ulcerative colitis/Crohn's disease (n = 336; observational studies). Published data were not available for ongoing studies in psoriasis patients. Four intended copies were identified in published studies (total: n = 1430; n = 1372 in observational studies). Thematic analysis of non-empirical publications showed that indication extrapolation remains an issue, particularly for gastroenterologists.

conclusionsWhile most agents display a moderate to high degree of similarity to their originator in the published studies identified, large discrepancies persist in the overall amount and type of data available in the public domain. Significant gaps exist particularly for intended copies, reinforcing the need to maintain a clear differentiation between these molecules and true biosimilars.

Indexed as

AdalimumabAnti-Inflammatory Agents, Non-SteroidalBiosimilar PharmaceuticalsClinical Trials as TopicColitis, UlcerativeCrohn DiseaseEtanerceptHumansInflammationInfliximabRituximabSerial PublicationsSpondylitis, AnkylosingAdalimumabAnti-Inflammatory Agents, Non-SteroidalBiosimilar PharmaceuticalsEtanerceptInfliximabRituximab

Identifiers

PMID27885553
PMCPMC5126192
OpenAlexW2550274663

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.