FDA Expands Dosing Options for OMLYCLO: What the New 300 mg Prefilled Syringe Means for Patients

FDA Expands Dosing Options for OMLYCLO: What the New 300 mg Prefilled Syringe Means for Patients

By, Admin 3 December 2025

The FDA has approved a new 300 mg/2 mL prefilled syringe presentation of OMLYCLO® (omalizumab-igec), the first and only interchangeable biosimilar to XOLAIR®. This update gives physicians and patients more flexibility, fewer injections, and a simpler treatment experience across several allergic and inflammatory conditions.

A Quick Recap: What’s New?

Celltrion has added a 300 mg single-dose prefilled syringe, expanding the previously approved 75 mg and 150 mg presentations. The goal is simple: reduce treatment burden and improve convenience.

Why It Matters?

  • Fewer injections for patients who need higher doses
  • Easier administration in clinics
  • More flexible dosing schedules
  • Broader access to an interchangeable biologic option

Dr. Juby Jacob-Nara from Celltrion USA called the approval “a milestone that broadens choices and reduces overall treatment burden.”
The commercial team added that the update strengthens Celltrion’s push to expand access to advanced biologics across the U.S.

What Conditions Does OMLYCLO Treat?

OMLYCLO is approved as an interchangeable biosimilar for all XOLAIR indications, including:

  • Moderate to severe asthma (ages ≥6)
  • Chronic rhinosinusitis with nasal polyps (ages ≥18)
  • IgE-mediated food allergy (ages ≥1), used with allergen avoidance
  • Chronic spontaneous urticaria (ages ≥12)

Its anti-IgE mechanism helps reduce allergic inflammation and prevents severe reactions, including those triggered by accidental food exposure.

Important Safety Notes

OMLYCLO carries a boxed warning for anaphylaxis. Because these reactions can occur even after long-term use, initiation must happen in a healthcare setting with trained supervision.

Other safety considerations include:

  • Risk of malignancy observed in trials
  • Not for acute asthma attacks
  • Monitoring required for eosinophilic conditions
  • Caution in helminth-endemic areas

The most common side effects include headache, injection-site reactions, dizziness, abdominal pain, and upper-respiratory infections, varying by indication.

About Celltrion and Celltrion USA

Celltrion is one of the world’s most established biosimilar developers, with a growing portfolio across immunology, oncology, hematology, ophthalmology, and endocrinology.
In the U.S., Celltrion USA markets a broad suite of biosimilars including INFLECTRA, HERZUMA, YUFLYMA, VEGZELMA, STOBOCLO, EYDENZELT, and the novel biologic ZYMFENTRA.

The company continues to expand access to high-quality biologics through its U.S. operations based in New Jersey.

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