New biosimilar aims to tame stubborn hives at lower cost

NCT ID NCT04976192

Completed Disease control Sponsor: Teva Pharmaceuticals USA Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 3 trial tested whether TEV-45779, a biosimilar of the drug omalizumab (XOLAIR), works as well as the original for people with chronic hives that don't improve with antihistamines. 608 participants received either the biosimilar or XOLAIR. The main goal was to compare changes in itch severity over 12 weeks. The study aims to show that the biosimilar is a safe and effective alternative.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: omalizumab (biosimilar TEV-45779)
What this could lead to: If successful, this could offer a more affordable alternative to XOLAIR for controlling chronic hives.
What could go wrong: This is a biosimilar comparison study, not a new treatment. The main risk is that TEV-45779 may not work as well as XOLAIR, or may have different side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria chronic urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHRONIC URTICARIA

Contacts and locations

Locations

10004

Salt Lake City, Utah, 84117, United States
10005

Miami, Florida, 33014, United States
10006

Kissimmee, Florida, 34744, United States
10007

Troy, Michigan, 48084, United States
10008

Bakersfield, California, 93301, United States
10009

Tampa, Florida, 33613, United States
10012

Coral Gables, Florida, 33134, United States
10014

Maitland, Florida, 32751, United States
Site 10001

Clearwater, Florida, 33765, United States

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