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

Clin Pharmacol Drug DevSep 1, 2026
Clinical ResearchAllergy & ImmunologyOpen access

Sunil Soitawala, Hiren Prajapati, Hiren Mehta et al.

✦ AI-curated · Sources linked

In 30 seconds

This randomized controlled trial evaluated the pharmacokinetic and pharmacodynamic bio-similarity of ADL-018, a biosimilar to omalizumab, in 306 healthy adults. The study found that ADL-018 was pharmacokinetically equivalent to both US-licensed and EU-approved omalizumab, with geometric mean ratios for AUC (0-last) of 1.08 and 1.06, respectively, confirming bioequivalence within the predefined margin.

Key findings

  • ADL-018 showed AUC (0-last) GMRs of 1.08 vs US-OMA and 1.06 vs EU-OMA, confirming bioequivalence.
  • Total IgE increase and free IgE decrease were comparable across all treatment arms.
  • The incidence of treatment-emergent adverse events was similar among ADL-018 (6), US-OMA (5), and EU-OMA (4).

Why it matters

The findings support the use of ADL-018 as a biosimilar to omalizumab, indicating it may provide similar efficacy and safety profiles, which is crucial for treatment decisions in allergy management.

Source

PubMed · PMID 42687583Free full text on PubMed Central

Published in Clin Pharmacol Drug Dev. This summary was written by xxcode from the publication's abstract and metadata. It is not peer reviewed and is not a substitute for the original article. For clinical decisions, review the original publication.

ShareTelegramLinkedIn

AI-generated summaries may contain errors or omissions. Verify clinically important information with the original publication.

More in Allergy & Immunology

Clinical ResearchOncology (Medical)

Osimertinib With or Without Chemotherapy in Advanced Non-Small Cell Lung Cancer With EGFR and Concurrent TP53 Mutations: A Randomized Clinical Trial.

This phase 3 randomized clinical trial evaluated the efficacy and safety of osimertinib combined with chemotherapy versus osimertinib alone in 294 patients with advanced non-small cell lung cancer (NSCLC) harboring…

JAMASep 8, 2026Open accessRead summary
Clinical ResearchHematology

Azacitidine-Venetoclax or Induction Chemotherapy for Acute Myeloid Leukemia.

This phase 2 randomized trial compared azacitidine plus venetoclax to induction chemotherapy in 172 previously untreated adults with acute myeloid leukemia (AML) eligible for induction.

N Engl J MedSep 3, 2026Read summary
Clinical ResearchPsychiatry

The efficacy of modified psychodynamic psychotherapy for patients with schizophrenia-spectrum disorders in Germany: a prospective, single-centre, assessor-blinded, parallel-group, randomised controlled trial.

This randomized controlled trial evaluated the efficacy of Modified Psychodynamic Psychotherapy for Schizophrenia (MPP-S) combined with treatment as usual (TAU) in 130 outpatients with schizophrenia-spectrum disorders…

Lancet PsychiatrySep 10, 2026Read summary

Want this personalized?

Stop searching the literature. Choose what you follow and xxcode will build your personalized medical digest.

  • Your specialties
  • Your filters and thresholds
  • Clinical Research + Case Reports, tuned separately
  • Automatic weekly delivery
  • Audio and text
Create my personalized digestSee plans

Prefer listening? Personalized audio digests are available with Pro.

Stay updated for free

Get the 3 most interesting publications in one specialty each week.

Weekly email. Unsubscribe anytime.