Evidence map›Paper›PMID 35881304›Full record

SynthesisBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2022

Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.

Hillel P Cohen, Sohaib Hachaichi, Wolfram Bodenmueller, Tore K Kvien, Silvio Danese, Andrew Blauvelt

Abstract readSystematic Review
In one paragraph

Synthesis in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

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

  1. Pooled it
  2. Review
  3. Review
  4. Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Article
  5. Article
  6. Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
  12. Article
  13. Article
  14. Review
  15. An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024
    Article
  16. Biosimilars in Dermatology Review.Journal of psoriasis and psoriatic arthritis · 2024
    Review
  17. Article
  18. Article
  19. Article
  20. Molecular Biosimilarity-An AI-Driven Paradigm Shift.International journal of molecular sciences · 2022
    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

6 authors.

Hillel P CohenSandoz Inc. (A Novartis Division), 100 College Road West, Princeton, NJ, 08540, USA. hillel.cohen@sandoz.com.ORCID http://orcid.org/0000-0002-8758-0890
Sohaib HachaichiSandoz Biopharmaceuticals, Holzkirchen, Germany.
Wolfram BodenmuellerSandoz Biopharmaceuticals, Holzkirchen, Germany.
Tore K KvienDivision of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0002-8441-3093
Silvio DaneseDepartment of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy.
Andrew BlauveltOregon Medical Research Center, Portland, OR, USA.ORCID http://orcid.org/0000-0002-2633-985X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple switches (transitions) between biosimilars of the same reference biologic are now a reality, and they are expected to become more common in the future as more biosimilars enter the market. Switching between two biosimilars of the same reference biologic is generally driven by affordability, formulary requirements, or the relocation/travel of the patient. Evidence of whether switching between biosimilars of the same reference biologic provides similar safety and efficacy profiles is reviewed here.

methodsA systematic search was undertaken using electronic databases (to December 2021): Biosis, Embase, MEDLINE, and EBM Reviews/Cochrane Database of Systematic Reviews via Ovid. Publications were evaluated for effectiveness and/or safety data linked to switching from one biosimilar to another.

resultsThe systematic search yielded 982 citations. After eliminating duplicates, 626 citations remained for the initial title/abstract screening phase. Following the initial screening, 240 records were chosen; more thorough examination yielded 35 citations. After comprehensive screening and expert advice, 23 studies were selected, of which 13 were published in peer-reviewed journals; the remainder have been published as abstracts. Overall, 3657 patients were included in these studies. All studies were observational in nature; no randomized clinical trials were identified. The studies were heterogeneous in size, design, and endpoints. Across the studies, data are provided on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns. The majority of studies examined switches between biosimilar infliximabs, although switches between biosimilar adalimumabs, etanercepts, and rituximabs were also identified. Two use-pattern studies and one case report were also detected and are discussed.

conclusionWithin the limitations of this systematic review, available data suggests that biosimilar-to-biosimilar switching is a safe and effective clinical practice, although it is not covered by current health authority regulations or guidance. No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date.

Indexed as

Biosimilar PharmaceuticalsDatabases, FactualHumansBiosimilar Pharmaceuticals

Identifiers

PMID35881304
PMCPMC9485085

What Socratic 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 Socratic graph.