Celltrion said Friday that it has applied for the clinical trials for CT-P17, an adalimumab biosimilar that treats rheumatoid arthritis, to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
Humira, the original medicine of CT-P17, is a therapeutic biopharmaceutical for the treatment of rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, and ankylosing spondylitis. The drug recorded a sale of $18.4 billion in 2017, making it the largest-selling blockbuster medicine in the world.
The company has differentiated its drug from its competitors by developing CT-P17 as a high-concentration formulation.
Celltrion is set to launch phase 1 clinical trials to confirm the safety and pharmacokinetic assessment of the adalimumab biosimilar in the U.K., while also conducting global phase 3 clinical trials in about 75 sites in eight nations in European region from August 2018. The company plans to complete phase 3 clinical trials by 2020.
After completing the clinical trials, Celltrion plans to maximize its market share in TNF-α inhibitor biosimilar markets under the strategy of diversifying its TNF-α inhibitors along with Remsima, which already owns 52 percent of Europe’s TNF-α inhibitor market, along with CT-P13 SC which is undergoing clinical trials with the goal of obtaining approvals in 2019.
The company also plans to launch global phase 3 clinical trials for CT-P16, an Avastin biosimilar that treats colorectal cancer.
Celltrion has completed clinical trials for the safety and pharmacokinetic evaluation of 'CT-P16' in Korea last year. Recently, it has applied for phase 3 clinical trials in Portugal.
Starting with Portugal, the company plans to apply for clinical trials sequentially to regulatory agencies in Europe, Latin America, and other countries and will conduct phase 3 clinical trials for CT-P16 at about 150 sites in 20 countries.
Avastin, the original product of CT-P16, is an anticancer drug used for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma. The therapy recorded a sale of 7.5 trillion won ($6.6 billion) last year.
“Celltrion is proceeding smoothly with the planned schedule for CT-P16," a company official said. "CT-P16 plans to secure differentiated competitiveness compared its competitors."
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