Evidence map›Paper›PMID 27729659›Full record

ReviewNature reviews. Gastroenterology & hepatology2017

Biosimilars in IBD: from theory to practice.

Silvio Danese, Stefanos Bonovas, Laurent Peyrin-Biroulet

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature reviews. Gastroenterology & hepatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 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

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  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

3 authors.

Silvio DaneseDepartment of Biomedical Sciences, Humanitas University, Via Manzoni 113, 20089 Rozzano, Milan, Italy.
Stefanos BonovasIBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Via Manzoni 56, 20089 Rozzano, Milan, Italy.
Laurent Peyrin-BirouletDepartment of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biologic agents have revolutionized the care management of many life-threatening and debilitating diseases. As patents for older biologic therapies have begun to expire, the market has opened to copy versions of the originators - commonly referred to as biosimilars, follow-on biologic agents or subsequent-entry biologic agents - which are expected to gain a portion of the market, reduce health-care spending and increase treatment access worldwide. Importantly for patients with IBD, CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the European Medicines Agency in September 2013 and by the FDA in April 2016. In May 2016, SB2 was the second biosimilar to infliximab receiving marketing authorization in Europe. Currently, >20 other biosimilars to infliximab and adalimumab are in the development pipeline. Their similar-but-not-identical nature, and the concept of extrapolating efficacy and safety data from one therapeutic indication to another, seem to be confusing to physicians and cause concerns about the efficacy and safety of biosimilar products. A relevant debate is still ongoing in the field of IBD. This Review discusses the scientific principles underlying the biosimilar concept established in Europe and the USA, and discusses the current state of knowledge on biosimilar use in IBD.

Indexed as

Biosimilar PharmaceuticalsClinical Trials as TopicDrug ApprovalDrug DiscoveryDrug LabelingHumansInflammatory Bowel DiseasesBiosimilar Pharmaceuticals

Identifiers

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.