Trial reportCancer chemotherapy and pharmacology2016
A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.
Trial report in Cancer chemotherapy and pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 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
27 citing papers in PubMed, 50 citations in OpenAlex.
- A phase I study comparing the biosimilarity of the pharmacokinetics and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection with AvastinBMC pharmacology & toxicology · 2023Trial
- A randomized, double-blind, single-dose study to assess bioequivalence of MB02 biosimilar after manufacturing iteration and reference bevacizumab.Pharmacology research & perspectives · 2023Trial
- Pharmacokinetics, Tolerability, Safety, and Immunogenicity of LY01008 and Bevacizumab (Avastin®) in Healthy Chinese Subjects.European journal of drug metabolism and pharmacokinetics · 2022Trial
- A randomized, double blind, single dose, comparative study of the pharmacokinetics, safety and immunogenicity of MB02 (bevacizumab biosimilar) and reference bevacizumab in healthy male volunteers.British journal of clinical pharmacology · 2022Trial
- A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab.Journal of cancer research and clinical oncology · 2022Trial
- A randomized, single-dose, pharmacokinetic equivalence study comparing MB02 (proposed biosimilar) and reference bevacizumab in healthy Japanese male volunteers.Cancer chemotherapy and pharmacology · 2021Trial
- A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers.Cancer chemotherapy and pharmacology · 2021Trial
- Trial
- A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers.Cancer chemotherapy and pharmacology · 2020Trial
- Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (AvastinCancer chemotherapy and pharmacology · 2020Trial
- A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects.Cancer chemotherapy and pharmacology · 2020Trial
- PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (AvastinBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019Trial
- A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with AvastinBritish journal of clinical pharmacology · 2018Trial
- Translational physiologically-based pharmacokinetic model for ocular disposition of monoclonal antibodies.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.Pharmaceutical medicine · 2024Article
- Physicochemical stability of PF-06439535 (bevacizumab-bvzr; ZirabevJournal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2023Article
- Development of the Drug Product Formulation of the Bevacizumab Biosimilar PF-06439535 (Bevacizumab-bvzr).Drugs in R&D · 2023Article
- Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials.European journal of hospital pharmacy : science and practice · 2022Article
- Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities.Pharmaceuticals (Basel, Switzerland) · 2021Article
- Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers.Frontiers in pharmacology · 2021Article
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
purposeThis study compared the pharmacokinetics of PF-06439535, a potential bevacizumab biosimilar, to bevacizumab sourced from the European Union (bevacizumab-EU) and USA (bevacizumab-US), and of bevacizumab-EU to bevacizumab-US.
methodsIn this double-blind study, 102 healthy males, aged 21-55 years, were randomized 1:1:1 to receive a single 5 mg/kg intravenous dose of PF-06439535, bevacizumab-EU, or bevacizumab-US. Pharmacokinetic assessments were conducted for 71 days, with additional safety and immunogenicity assessments until day 100. Pharmacokinetic similarity was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the maximum serum concentration (C max), area under the serum concentration-time curve from zero to infinity (AUC0-∞), and from zero to time of last quantifiable concentration (AUC0-t ) were within the 80.00-125.00 % bioequivalence acceptance window.
resultsThe three study drugs exhibited similar pharmacokinetic properties. For the comparisons of PF-06439535 to bevacizumab-EU or bevacizumab-US, and of bevacizumab-EU to bevacizumab-US, the 90 % CIs for the ratios of C max, AUC0-t , and AUC0-∞ were all within 80.00-125.00 %. Two, one, and two subjects treated with PF-06439535, bevacizumab-EU, and bevacizumab-US, respectively, tested positive for antidrug antibodies, none of whom tested positive for neutralizing antibodies. Treatment-related adverse events were reported in 15.2, 25.7, and 18.2 % of subjects in the PF-06439535, bevacizumab-EU, and bevacizumab-US treatment arms, respectively.
conclusionsThis study demonstrated the pharmacokinetic similarity of PF-06439535 to both bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. The safety profile (including immunogenicity) was similar in the three treatment groups, with no significant safety findings reported.
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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.