Celltrion's 'Omriclo', CHMP Recommends Approval for AI-Formulation Addition

Laying the Groundwork for European Market Leadership
Expanding Personalized Treatment and Accelerating Entry into the Self-Injection Market

Celltrion announced on the 31st that it received a recommendation for approval of a change to add the 'Omriclo' auto-injector (AI) formulation from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

Celltrion

Omriclo is a biosimilar of Xolair, which secured first-mover status by obtaining the first marketing authorization in Europe in May last year.

This approval recommendation is a change to additionally approve the 75mg/150mg AI formulation following the previously authorized 75mg/150mg prefilled syringe (PFS) formulation. The purpose is to expand self-injection options for patients and enhance treatment convenience.

Celltrion demonstrated efficacy equivalence and safety similarity compared to the original drug through the global Phase 3 clinical trial of CT-P39 involving 619 patients with chronic spontaneous urticaria.

The original drug Xolair, which Omriclo is based on, is an antibody biopharmaceutical used for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. It recorded approximately KRW 6 trillion in global sales as of last year. Recently, in the U.S., the original drug Xolair also received approval for the food allergy indication, which is expected to further expand the market size.

Celltrion expects that the AI formulation, being more convenient for self-administration compared to the existing PFS formulation, will improve treatment accessibility for patients who have difficulty visiting medical institutions and enhance treatment satisfaction for patients who prefer self-injection.

Especially in major European countries, as demand for self-injection formulations increases, the preference for AI formulations that improve patient convenience is steadily rising. Based on the approval recommendation for the Omriclo AI change, market expansion and increased market share in Europe are anticipated.

A Celltrion official stated, "The Omriclo AI formulation is significant in that it allows selective administration according to the patient's condition and preference along with the previously authorized PFS formulation," adding, "We plan to enhance treatment accessibility and convenience through formulation diversification and strengthen market competitiveness by securing excellent stability and shelf life."

This content was produced with the assistance of AI translation services.