ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026
Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
What it found
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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 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
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No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
BACKGROUND AND
objectiveCT-P16 (Vegzelma
methodsConcentration data from one phase III trial (NCT03676192) and two phase I trials (NCT03247673; CT-P16 1.2) were pooled. The population pharmacokinetic analysis used nonlinear mixed-effects modelling in NONMEM
resultsA total of 8058 serum concentrations from 834 subjects (phase I: 187 healthy male volunteers; phase III: 649 patients with non-small cell lung cancer) were analyzed. A two-compartment model with first-order elimination adequately described the pooled data. Body weight, sex, and disease status were retained as covariates on clearance; sex, baseline serum albumin, and disease status were retained on central volume of distribution. Drug product was not retained as a significant covariate, indicating no clinically meaningful difference between CT-P16 and either EU-Avastin
conclusionsWithin a unified population pharmacokinetic framework, CT-P16 demonstrated comparable pharmacokinetics to both EU-Avastin CLINICAL
trial registrationNCT03247673; NCT03676192.
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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.