Celltrion announced Friday that it has obtained product approval from the Japanese Ministry of Health, Labor and Welfare for Omlyclo, a biosimilar of allergic disease treatment Xolair, and Eydenzelt, a biosimilar of the ophthalmic disease treatment Eylea.
"This is an opportunity to further strengthen our influence in the Japanese market," an official from Celltrion said. "Based on the performance of our existing flagship lineup, we will do our best to facilitate the early adoption of our latest products as well."
Omlyclo has secured the status of a "first mover," as the first Xolair biosimilar to be approved in Japan. It received approval for all indications held by the original drug, including bronchial asthma, idiopathic chronic urticaria and seasonal allergic rhinitis, the company said.
Eydenzelt is entering the market after securing indications for major ophthalmic diseases such as macular degeneration and diabetic macular edema. By offering both vial and prefilled syringe formulations, the company said it is positioned to meet requirements across diverse medical settings.
"Based on the strong performance of our flagship products, we plan to accelerate the rollout of the newly approved lineup and expand its share in the market," Celltrion said.
According to clinical research provider IQVIA and local data, breast cancer treatment Herceptin secured a 76 percent market share in Japan, maintaining its position as the No. 1 prescribed trastuzumab treatment for 4 1/2 years. Begzelma, building on this momentum, leads the market with a 58 percent market share.
By Lee Han-gyoul (stlee0329@heraldcorp.com)
