Evidence map›Paper›PMID 26509046›Full record

ArticleRMD open2015

Biosimilars in rheumatology: what the clinician should know.

Gilberto Castañeda-Hernández, Rodrigo González-Ramírez, Jonathan Kay, Morton A Scheinberg

Abstract read
In one paragraph

Article in RMD open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
–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

29 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
    Pooled it
  2. Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016
    Pooled it
  3. Trial
  4. Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  5. The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. PANLAR consensus statement on biosimilars.Clinical rheumatology · 2019
    Article
  16. Practical Guidance on Biosimilars, With a Focus on Latin America: What Do Rheumatologists Need to Know?Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2019
    Review
  17. Review
  18. Article
  19. Article
  20. 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

4 authors.

Gilberto Castañeda-HernándezDepartamento de Farmacología , Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional , México, Distrito Federal , Mexico ; Centro Latino Americano de Pesquisa em Biológicos , Rio de Janeiro , Brazil.
Rodrigo González-RamírezDepartamento de Farmacología , Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional , México, Distrito Federal , Mexico.
Jonathan KayDivision of Rheumatology, Department of Medicine , University of Massachusetts Medical School and UMass Memorial Medical Center , Worcester, Massachusetts , USA.
Morton A ScheinbergHospital AACD , São Paulo, São Paulo , Brazil ; Hospital Israelita Albert Einstein , São Paulo, São Paulo , Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biosimilars are now a reality in rheumatology. Although analytical and non-clinical procedures to establish similarity have evolved significantly, clinical trials demonstrating equivalent efficacy and safety are absolutely required for all biosimilars. The design of such trials, including equivalence and non-inferiority statistical approaches, are discussed. Clinical evidence on biosimilars that have been approved recently or are presently being developed for use in rheumatology is also reviewed and contrasted with that available for biomimics (or intended copies), which are non-innovator biologics that are marketed in several countries but have not undergone review according to a regulatory pathway for biosimilars.

Indexed as

Anti-TNFOutcomes researchPharmacokinetics

Identifiers

PMID26509046
PMCPMC4613175

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.