Evidence map›Paper›PMID 34705255›Full record

ReviewDrugs2021

Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

Eduardo Mysler, Valderilio Feijó Azevedo, Silvio Danese, Daniel Alvarez, Noriko Iikuni, Beverly Ingram, Markus Mueller, Laurent Peyrin-Biroulet

Abstract readReview
In one paragraph

Review in Drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 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

27 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Pooled it
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Evaluation of rheumatologists' knowledge of biosimilars.Advances in rheumatology (London, England) · 2025
    Article
  9. Review
  10. Review
  11. Review
  12. Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
  13. Review
  14. Review
  15. Unveiling the Biosimilar Paradox of Oncologists' Perceptions and Hesitations in South Korea: A Web-Based Survey Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Article
  16. Article
  17. Article
  18. Article
  19. Navigating adalimumab biosimilars: an expert opinion.Journal of comparative effectiveness research · 2023
    Review
  20. 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

8 authors.

Eduardo MyslerOrganización Médica de Investigación, Buenos Aires, Argentina. E.mysler@omiargentina.com.ar.ORCID http://orcid.org/0000-0002-8993-0313
Valderilio Feijó AzevedoRheumatology Unit, Department of Internal Medicine, Federal University of Paraná, Curitiba, PR, Brazil.ORCID http://orcid.org/0000-0002-2346-388X
Silvio DaneseGastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.ORCID http://orcid.org/0000-0001-7341-1351
Daniel AlvarezPfizer Inc, Collegeville, PA, USA.
Noriko IikuniPfizer Inc, New York, NY, USA.ORCID http://orcid.org/0000-0002-5541-9314
Beverly IngramPfizer Inc, Boston, MA, USA.
Markus MuellerPfizer Pharma GmbH, Berlin, Germany.
Laurent Peyrin-BirouletDepartment of Gastroenterology and Inserm U1256 NGERE, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.ORCID http://orcid.org/0000-0003-2536-6618

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clinical practice, across a diverse range of patients, the option to cross-switch from one biosimilar to another can and does arise for valid reasons such as convenience or tolerability issues, or driven by third parties (e.g., payers). In the absence of clinical trial data, clinicians must attempt to objectively evaluate the emerging real-world cross-switching evidence within the context of what is known about the science underpinning a designation of biosimilar. That knowledge then needs to be integrated with what clinicians know about their patients and their disease on a case-by-case basis. This review aims to consolidate relevant emerging real-world data and other key information about biosimilar-to-biosimilar cross-switching for prescribing clinicians. In the absence of clear clinical guidelines addressing this topic at present, this review may serve to facilitate discretionary and educated treatment decision making.

Indexed as

Drug SubstitutionAnimalsBiological ProductsBiosimilar PharmaceuticalsDecision MakingHumansPractice Patterns, Physicians'Randomized Controlled Trials as TopicBiological ProductsBiosimilar Pharmaceuticals

Identifiers

PMID34705255
PMCPMC8578069

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.