Evidence map›Paper›PMID 40560336›Full record

SynthesisInternational journal of clinical pharmacy2025

Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence.

Chin Hang Yiu, Grace Tsz Yan Yau, Zoi Hei Wong, Chen-Yun Lin, Richard O Day, Jacques Raubenheimer, Christine Y Lu

Abstract readSystematic ReviewComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in International journal of clinical pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Relapse of retinal vasculitis after a non-medical biosimilar switch: a case report.Journal of ophthalmic inflammation and infection · 2026
    Article
  6. Article
  7. 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

7 authors.

Chin Hang YiuThe University of Sydney School of Pharmacy, Camperdown, NSW, Australia. chin.yiu@sydney.edu.au.ORCID http://orcid.org/0000-0001-7758-6087
Grace Tsz Yan YauThe University of Sydney School of Pharmacy, Camperdown, NSW, Australia.ORCID http://orcid.org/0009-0004-2400-8733
Zoi Hei WongSchool of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
Chen-Yun LinSchool of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
Richard O DayDepartment of Clinical Pharmacology & Toxicology, St Vincent's Hospital Sydney and St Vincent's Clinical Campus, UNSW Medicine, Sydney, NSW, Australia.ORCID http://orcid.org/0000-0002-6045-6937
Jacques RaubenheimerThe University of Sydney School of Pharmacy, Camperdown, NSW, Australia.ORCID http://orcid.org/0000-0003-3907-304X
Christine Y LuThe University of Sydney School of Pharmacy, Camperdown, NSW, Australia.ORCID http://orcid.org/0000-0002-7550-6837

Funding

University of Sydney University of Sydney Postgraduate Award
6 · The paper itself

Abstract

backgroundEffective management of rheumatoid arthritis (RA) often requires the use of biological disease-modifying antirheumatic drugs (bDMARDs). Biosimilar drugs (biosimilars), licensed pharmaceutical products that exhibit high similarity to their reference biological products (originators), have emerged as more affordable alternatives.

aimTo compare the real-world effectiveness and safety of biosimilars and originators of bDMARDs in the management of RA at treatment initiation.

methodA systematic literature search was conducted using PubMed, MEDLINE, Embase, Scopus, International Pharmaceutical Abstract and CINAHL from database inception to 18th April 2025. Observational studies utilising real-world data (e.g., electronic health records, biologics registries) that compared clinical outcomes between patients initiating treatment with either a biosimilar or an originator for RA were included. Quality assessment was conducted using the Newcastle-Ottawa Scale (NOS) and a narrative synthesis was conducted to summarise key findings.

resultsA total of 13 retrospective cohort studies were included, providing data on 34,280 patients initiating treatment with bDMARDs for RA. Treatment retention was the most investigated effectiveness outcome (n = 11), and all studies found that biosimilars were associated with comparable retention profiles compared to originators. No significant differences were identified for other effectiveness outcomes (e.g., disease activity indices). For safety outcomes, adverse events (AEs) were documented in eight studies. However, seven of these studies were of poor quality in assessing safety outcomes due to inadequate control for confounding factors.

conclusionIn real-world settings, biosimilars generally demonstrate comparable effectiveness to originators. Future investigations are warranted to examine the comparative safety profiles of biosimilars and originators.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiological ProductsBiosimilar PharmaceuticalsHumansObservational Studies as TopicRetrospective StudiesTreatment OutcomeAntirheumatic AgentsBiological ProductsBiosimilar PharmaceuticalsBiologicsBiosimilarsReal-world evidenceRheumatoid arthritis

Identifiers

PMID40560336
PMCPMC12630288

What OpenQuestion holds

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LicenceCC BY
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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.