Trial reportDrug design, development and therapy2018
Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects.
Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02326233 (A Randomised, Open-labelled, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Pre-filled Pen and PFS of SB5 in Healthy Subjects), which is not on this map. Cited by 9 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.
A Randomised, Open-labelled, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Pre-filled Pen and PFS of SB5 in Healthy Subjects
Who cites it
9 citing papers in PubMed, 20 citations in OpenAlex.
- Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects.British journal of clinical pharmacology · 2021Trial
- Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects.Clinical pharmacology in drug development · 2021Trial
- A Randomized, Double-Blind, Parallel-Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects.Clinical pharmacology in drug development · 2021Trial
- Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Self-Injection Satisfaction and Safety of CT-P17 (Yuflyma), a High-Concentration Adalimumab Biosimilar, in Patients With Crohn's Disease: A Cross-Sectional Study.JGH open : an open access journal of gastroenterology and hepatology · 2025Article
- Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases.Advances in therapy · 2024Review
- Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.Clinical drug investigation · 2023Review
- Comparison of Efficacy and Safety of Original and Biosimilar Adalimumab in Active Rheumatoid Arthritis in a Real-World National Cohort.Medicina (Kaunas, Lithuania) · 2022Observational
- Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA.Pediatric rheumatology online journal · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe objective of this study was to demonstrate comparable pharmacokinetic (PK), safety, and tolerability parameters of the adalimumab biosimilar SB5 administered via autoinjector (AI) pen or prefilled syringe (PFS). PATIENTS AND
methodsIn this phase 1, randomized, open-label, single-dose, parallel-group study, healthy subjects aged 18-55 years were randomized 1:1 to a single dose of 40 mg SB5 delivered subcutaneously via AI or PFS. PK parameters, safety, and tolerability were assessed for 57 days post-dose. The primary endpoint was area under the curve (AUC) of the concentration-time curve from zero to infinity (AUC
resultsNinety-five subjects were randomized to each group. Mean serum concentration-time profiles were superimposable between groups. Mean values for AUC
conclusionIn healthy subjects receiving a single dose of SB5 via AI or PFS, PK parameters and corresponding 90% CIs were within the predefined margins, showing bioequivalence between the two delivery methods. Safety and tolerability assessments were also similar between groups. CLINICALTRIALSGOV IDENTIFIER: NCT02326233. EUDRACT NUMBER: 2014-005178-12.
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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.