Celltrion said it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a variation application to add an autoinjector (AI) formulation to its omalizumab biosimilar, Omlyclo.

Omlyclo is a biopharmaceutical antibody with the same composition as the original drug, Novartis' Xolair, and it has indications that include allergic asthma and chronic idiopathic urticaria. Xolair recorded approximately 6 trillion won ($4.1 billion) in global sales in 2024.

Omlyclo was first approved in the EU in May 2024, making Celltrion the first company to receive regulatory clearance for the product in Europe.

The newly recommended AI formulation covers the same 75mg and 150mg doses previously approved in pre-filled syringe (PFS) form. The addition aims to expand self-injection options for patients and enhance treatment convenience, especially for those with limited access to healthcare facilities or who prefer self-administration.

Celltrion demonstrated the efficacy and equivalence of CT-P39 compared to the reference product through a global phase 3 clinical trial involving 619 patients with chronic spontaneous urticaria. The study also confirmed a comparable safety profile.

Celltrion expects the AI formulation to improve treatment accessibility for patients who face challenges visiting healthcare facilities and to boost satisfaction among those who prefer home-based self-injection. The company noted that demand for autoinjectors is on the rise in major European markets, where patient preference continues to shift toward more user-friendly drug delivery formats.

“With the addition of the AI version to our existing PFS (prefilled syringe) formulation, patients can now choose based on their individual needs and preferences,” a company official said. “This enhanced flexibility, combined with our product’s strong safety profile and shelf life, will strengthen our competitiveness in the market.”