Evidence map›Paper›PMID 42687583›Full record

Trial reportClinical pharmacology in drug development2026

Pharmacokinetic and Pharmacodynamic Bio-Similarity of ADL-018 to Innovator Omalizumab: A Randomized Study in Healthy Adults.

Sunil Soitawala, Hiren Prajapati, Hiren Mehta, Pawan Kumar Singh

Abstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

4 authors.

Sunil SoitawalaClinical Research Department, Veeda Clinical Research Ltd., Mehsana, Gujarat, India.
Hiren PrajapatiClinical Research Department, Veeda Clinical Research Ltd., Ahmedabad, Gujarat, India.
Hiren MehtaClinical Affairs/Biometrics Department, Veeda Clinical Research Ltd., Ahmedabad, Gujarat, India.
Pawan Kumar SinghKashiv Biosciences, LLC, Ahmedabad, Gujarat, India.

Funding

Kashiv BioSciences, LLC, USA
6 · The paper itself

Abstract

Bioequivalence and safety of ADL-018, an omalizumab biosimilar, were compared with United States-licensed omalizumab (US-OMA) and European Union-approved omalizumab (EU-OMA), both approved for allergies. Healthy adults were randomized (1:1:1) to receive a dose of ADL-018, US-OMA, or EU-OMA (150 mg/mL). Pharmacokinetic (PK) parameters, including AUC

Indexed as

Anti-Allergic AgentsBiosimilar PharmaceuticalsOmalizumabAdolescentAdultArea Under CurveCross-Over StudiesDouble-Blind MethodFemaleHealthy VolunteersHumansImmunoglobulin EMaleMiddle AgedTherapeutic EquivalencyYoung AdultAnti-Allergic AgentsBiosimilar PharmaceuticalsImmunoglobulin EOmalizumabADL‐018biosimilarpharmacodynamicspharmacokineticssafety

Identifiers

PMID42687583
PMCPMC13539287

What OpenQuestion holds

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Registered trials

None linked

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.