Omlyclo — licensed biologic

Overview

Source: Purple Book

Proprietary name

Omlyclo

Proper name

omalizumab-igec

Licence type

351(k) Interchangeable

BLA number

761399

Applicant

CELLTRION, Inc.

Center

CDER

Presentations

3

First licensure

—

351(k) biosimilar pathway. This product was licensed as highly similar to a reference product, with no clinically meaningful differences in safety, purity or potency. It also carries the interchangeable designation, so a pharmacist may substitute it for the reference product without contacting the prescriber.

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
150MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 7, 2025
300MG/2ML (150MG/ML)	Injection	Subcutaneous	Pre-Filled Syringe	Rx	December 1, 2025
75MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 7, 2025

Reference product

Source: Purple Book

This product is licensed with reference to Xolair (omalizumab).

View reference product Search the small-molecule catalogue

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity