Celltrion Inc. has received marketing authorization for its Humira biosimilar CT-P17 in Europe, becoming the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation in the world, according to the company on Monday.
The approval followed a positive opinion for the drug from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) about two months ago.
Celltrion shares ended up 0.3 percent at 333,000 won ($302.34), and Celltrion Healthcare shares up 1.27 percent at 143,200 won on Monday.
Celltrion plans to launch CT-P17 under the brand name of Yuflyma, which will broaden treatment alternatives for patients suffering from rheumatoid arthritis, inflammatory bowel disease, psoriasis and other Humira indications.
The high concentration (100mg/mL) and citrate-free formulation is designed to cut the dosage of the existing product by half and remove citrate-caused pain. Other Humira biosimilars are mostly low concentration drugs.
Humira developed by U.S. AbbVie generated about 22 trillion won ($20 billion) in global sales last year. More than 90 percent of AbbVie’s Humira products are high concentration formulations, which were first approved in Europe in 2015.
Celltrion said it will advance efforts to launch the drug by accelerating drug listing procedures across Europe through its global marketing and distribution affiliate Celltrion Healthcare.
By Kim Byung-ho and Minu Kim
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