Celltrion applies for trials of AbbVie's Humira biosimilar CT-P17 to MHRA
Celltrion applied for the clinical trials for its adalimumab biosimilar, or CT-P17, as a rheumatoid arthritis therapeutic agent, to the Medicines and Healthcare Products Regulatory Agency, or MHRA, in the UK. Celltrion is set to launch phase 1 clinical trials for the safety and pharmacokinetic assessment of the adalimumab biosimilar in the UK. And Celltrion also conducts global phase 3 clinical trials in about 75 sites in eight nations in European region from August. It aims to complete phase 3 clinical trials by 2020. Abbvie's Humira, the original medicine of CT-P17, is a therapeutic biopharmaceutical for the treatment of rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, ankylosing spondylitis, etc., and it recorded sales of about $18.4B in 2017. Celltrion has developed CT-P17 as a high-concentration formulation and thus differentiated it from the competitive biosimilars which are conducting clinical trials or have already been approved. Meanwhile, after completing clinical trials for CT-P17, Celltrion is set to maximize its market share in TNF-a inhibitor biosimilar markets under the strategy of diversifying its TNF-a inhibitors along with Remsima, already sharing 52%2 of the Europe's original medicine market, and CT-P13 SC which is undergoing clinical trials with the goal of obtaining approvals in 2019.