Evidence map›Paper›PMID 25456378›Full record

ReviewThe Lancet. Oncology2014

Regulatory and clinical considerations for biosimilar oncology drugs.

Charles L Bennett, Brian Chen, Terhi Hermanson, Michael D Wyatt, Richard M Schulz, Peter Georgantopoulos, Samuel Kessler, Dennis W Raisch, Zaina P Qureshi, Z Kevin Lu and 11 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet. Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
–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

44 citing papers in PubMed.

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  10. Maximizing the benefits of using biosimilars in Egypt.Journal of pharmaceutical policy and practice · 2023
    Article
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  12. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Charles L BennettThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bennettc@sccp.sc.edu.
Brian ChenThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA.
Terhi HermansonDepartment of Oncology, Helsinki University Central Hospital, Helsinki, Finland.
Michael D WyattThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
Richard M SchulzThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
Peter GeorgantopoulosThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA.
Samuel KesslerThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
Dennis W RaischUniversity of New Mexico, College of Pharmacy, Albuquerque, NM, USA.
Zaina P QureshiThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA.
Z Kevin LuThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA.
Bryan L LoveThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA.
Virginia NoxonThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
Laura BoboltsOncology Analytics Inc, Plantation, FL, USA; Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL, USA.
Melissa ArmitageOncology Analytics Inc, Plantation, FL, USA; University of South Florida College of Pharmacy, Tampa, FL, USA.
John BianThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
Paul RayThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; Midwestern University, Downers Grove, IL, USA.
Richard J AblinThe Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of Arizona College of Medicine, Tucson, AZ, USA.
William J HrusheskyUniversity of South Carolina, Arnold School of Public Health, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA; Oncology Analytics Inc, Plantation, FL, USA.
Iain C MacdougallKing's College Hospital, London, UK.
Oliver SartorTulane University School of Medicine, New Orleans, LA, USA.
James O ArmitageUniversity of Nebraska Medical Center, Omaha, NE, USA.

Funding

Southern Oncology Network on Adverse Reactions (SONAR) - Focus on Tyrosine KinaseR01CA165609 · NCI · UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA · PI BENNETT, CHARLES L. · 2012 to 2016
$2.2M
NCI NIH HHS 1R01CA165609-01A1NCI NIH HHS R01 CA165609
6 · The paper itself

Abstract

Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.

Indexed as

Antineoplastic AgentsBiosimilar PharmaceuticalsDrug ApprovalHumansNeoplasmsAntineoplastic AgentsBiosimilar Pharmaceuticals

Identifiers

PMID25456378
PMCPMC4404762

What OpenQuestion holds

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Registered trials

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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.