ReviewmAbs2015
Clinical considerations for the development of biosimilars in oncology.
Review in mAbs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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.
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.
Who cites it
23 citing papers in PubMed.
- A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (ActemraAnnals of medicine · 2021Trial
- A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.Cancer chemotherapy and pharmacology · 2016Trial
- An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption.Medicina (Kaunas, Lithuania) · 2022Review
- Preclinical pharmacology and toxicology evaluation of an anti-CD52 monoclonal antibody produced by perfusion fermentation process.Journal of industrial microbiology & biotechnology · 2021Article
- A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male Subjects.Frontiers in pharmacology · 2021Article
- A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men.Frontiers in pharmacology · 2020Article
- A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects.Frontiers in pharmacology · 2020Article
- Current perspectives on biosimilars.Journal of industrial microbiology & biotechnology · 2019Review
- Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust.The oncologist · 2018Review
- Biosimilars: Review of current applications, obstacles, and their future in medicine.World journal of clinical cases · 2018Article
- Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future.Dermatology and therapy · 2018Review
- Erythropoiesis-Stimulating Agents in the Management of Anemia in Chronic Kidney Disease or Cancer: A Historical Perspective.Frontiers in pharmacology · 2018Review
- Biosimilars Have Arrived: Rituximab.Arthritis · 2018Review
- Clinical equivalence with G-CSF biosimilars: methodologic approach in a (neo)adjuvant setting in non-metastatic breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Review
- Review
- Biosimilars and the extrapolation of indications for inflammatory conditions.Biologics : targets & therapy · 2017Review
- A practical guide about biosimilar data for health care providers treating inflammatory diseases.Biologics : targets & therapy · 2017Review
- Biosimilars: potential implications for clinicians.Clinical, cosmetic and investigational dermatology · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Despite availability of biologic therapies, limited patient access to many of the most-effective cancer treatments affects overall health outcomes. To address this issue, many governments have enacted legislation for the approval of biosimilars. The term "biosimilar" refers to a biologic product that is developed to be highly similar, as opposed to identical, to a licensed biologic product (the reference or innovator product), such that, per US Food and Drug administration draft guidelines, "no clinically meaningful differences [exist] between the biological product and the reference product in terms of safety, purity, and potency." This article presents some considerations about the development of biosimilars in cancer treatment through an overview of biosimilars from a clinical perspective. Topics covered include the development requirements and unique regulatory requirements for biosimilars, labeling considerations, potential limitations to the uptake of biosimilars, and review of some biosimilars in development for oncology indications.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.