Celltrion announced on the 31st that it received a recommendation for approval from the European Medicines Agency (EMA) under the Committee for Medicinal Products for Human Use (CHMP) regarding the additional automated injection (AI) formulation of 'Omlyclo (OMLYCLO).'
Omlyclo is a biosimilar of Xolair (omalizumab), jointly developed by U.S. company Novartis and Swiss company Roche. Xolair is an antibody treatment used for asthma and chronic idiopathic urticaria, which recorded worldwide sales of approximately 6 trillion won last year. Recently, the indication has been expanded in the U.S. to include food allergies, making the market size expected to grow further. Omlyclo was approved in Europe as the first biosimilar of Xolair in May last year.
This recommendation for approval is an amendment to add the 75 mg and 150 mg AI formulations following those of the previously approved 75 mg and 150 mg prefilled syringe (PFS) formulation, with the aim of expanding patient self-injection options and enhancing treatment convenience.
Celltrion confirmed the efficacy and safety of Omlyclo in a global Phase 3 clinical trial involving 619 patients with chronic idiopathic urticaria compared to Xolair. The company anticipates that the AI formulation, being more convenient for self-administration than 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.
A representative from Celltrion said, "We plan to enhance market competitiveness by increasing treatment accessibility and convenience through formulation diversification, as well as securing excellent stability and shelf life."