Celltrion demonstrated efficacy and equivalency to the original drug and confirmed safety similarity in the global phase 3 clinical trial of 'CT-P39,' involving 619 patients with chronic idiopathic urticaria in 6 European countries.

Based on the clinical results, Celltrion submitted the approval application to Health Canada for the full indications approved for the original drug, including allergic asthma, chronic rhinosinusitis, and chronic urticaria.

In the first half of 2010, Celltrion completed regulatory filings in Europe and Korea and plans to file in other major markets, including the United States.

XOLAIR, the originator of 'CT-P39', is an antibody biopharmaceutical co-developed by Genentech and Novartis, used for treating allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria.

As a blockbuster product with global sales of approximately KRW 5 trillion (approximately USD 3.8 billion) last year, XOLAIR’s material patent has expired, and the formulation patent expires in March 2024 in Europe and November 2025 in the United States.

Canada has been implementing a biosimilar friendly policy since 2019, with Prince Edward Island recently becoming the 11th province out of 13 Canadian provinces to adopt a biosimilar conversion policy.

Canada is actively fostering an environment supportive of biosimilar prescriptions, signaling ongoing market expansion.

“Recently, favorable biosimilar policies are expanding globally, including Canada, the United States, and Europe,” a Celltrion official noted.

"We are expanding our portfolio to include treatments for allergies and other diseases, in addition to our success in autoimmune and oncology drugs," the official added. "We are committed to the delivery of high-quality biopharmaceuticals and the improvement of access to treatment for patients."

Meanwhile, Celltrion aims to have a portfolio of 11 biosimilars by early 2025 and a total of 22 biosimilars by 2030, in addition to the six products already on the market.

Source:- The Bio