Celltrion said Thursday that it has completed registering patients for its global phase 3 clinical trial into CT-P17, a Humira biosimilar candidate.
|Celltrion headquarters in Incheon|
Humira, developed by Abbvie, 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. Unlike competitive biosimilars, the company also developed CT-P17 as a citrate free formulation, which can reduce the pain of the injection as it does not have a citrate buffer.
“As we have completed patient recruitment faster than planned, we expect to shorten the global launch schedule of CT-P17,” a company official said. “Celltrion will accelerate its plan launch the biosimilar which meets the requirements of regulatory agencies in the market as soon to help improve patient's quality of life.”
Celltrion plans to maximize its share in the 43 trillion won ($37.8 billion) global tumor necrosis factor-alpha (TNF-α) market, along with Remsima and Remsima SC.
According to IQVIQ, a market research agency, Remsima holds 56 percent of the EU's TNF-α market, while the company expects to receive regulatory approval for Remsima SC from the European Medicines Agency this year.