Evidence map›Paper›PMID 41857488›Full record

Trial reportPharmacology research & perspectives2026

Pharmacokinetic, Safety, and Immunogenicity Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab-Atto.

Vincent Chow, Muhan Zhou, Daniel T Mytych, Alexander Colbert, Mieke Jill Miller, Iwona Wala, Ahad Sabet, Waldemar Radziszewski

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pharmacology research & perspectives, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05909852 (A Randomized, Single-blind, Single-dose, 2-arm, Parallel-group Study to Determine the Pharmacokinetic Comparability of ABP 501 40 mg/0.4 mL), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05909852 phase1completednot on this map

A Randomized, Single-blind, Single-dose, 2-arm, Parallel-group Study to Determine the Pharmacokinetic Comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 mL (ABP 501-LCF) in Healthy Adult Subjects

TypeinterventionalSponsorAmgenRan2021 to 2021Enrolled372ConditionsAdalimumabArmsABP 501-HCF, ABP 501-LCF
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Vincent ChowAmgen Inc., Thousand Oaks, California, USA.
Muhan ZhouAmgen Inc., Thousand Oaks, California, USA.
Daniel T MytychAmgen Inc., Thousand Oaks, California, USA.
Alexander ColbertAmgen Inc., Thousand Oaks, California, USA.
Mieke Jill MillerAmgen Inc., Thousand Oaks, California, USA.
Iwona WalaAmgen Inc., Thousand Oaks, California, USA.
Ahad SabetIcon, Salt Lake City, Utah, USA.
Waldemar RadziszewskiAmgen Inc., Thousand Oaks, California, USA.ORCID https://orcid.org/0000-0001-5254-7436

Funding

Amgen
6 · The paper itself

Abstract

ABP 501, a monoclonal anti-tumor necrosis factor antibody, was the first adalimumab biosimilar approved in the US and EU as a 50 mg/mL formulation. An ABP 501 100 mg/mL high-concentration formulation is also now approved. This study compares pharmacokinetics (PK), safety, and immunogenicity of the low- (ABP 501-LCF) and high-concentration (ABP 501-HCF) formulations in healthy adults. This was a randomized, single-blind, single-dose, parallel-group study in healthy adults. Participants were randomized to receive 40 mg of ABP 501 as HCF or LCF. Primary PK endpoints were area under the concentration-time curve from time 0 extrapolated to infinity (AUC

Indexed as

AdalimumabBiosimilar PharmaceuticalsAdultArea Under CurveFemaleHealthy VolunteersHumansMaleMiddle AgedSingle-Blind MethodTherapeutic EquivalencyYoung AdultABP 501AdalimumabBiosimilar PharmaceuticalsABP 501adalimumabadalimumab‐attobiosimilarhigh‐concentrationpharmacokineticssafety

Identifiers

PMID41857488
PMCPMC13140478

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.