Clinical Trials

Date: 2018-08-07

Type of information: Submission of a clinical trial application

phase: 1

Announcement: submission of a clinical trial application

Company: Celltrion Healthcare (South Korea)

Product: CT-P17 (biosimilar version of Humira® - adalimumab)

Action mechanism:

monoclonal antibody/biosimilar product/TNF alpha inhibitor. CT-P17 is a biosimilar version of the monoclonal antibody adalimumab (Humira®). Adalimumab specifically binds to tumor necrosis factor (TNF)-alpha.

Disease: rheumatoid arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country: UK

Trial details:

Latest news:

• On August 7, 2018, Celltrion applied for the clinical trials for its adalimumab biosimilar ‘CT-P17’, as a rheumatoid arthritis therapeutic agent, to the MHRA (Medicines and Healthcare Products Regulatory Agency) 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.
Meanwhile, after completing clinical trials for CT-P17, Celltrion is set to maximize its market share in TNF-? inhibitor biosimilar markets under the strategy of diversifying its TNF-? inhibitors along with Remsima®, already sharing 52% of the Europe’s original medicine market, and CT-P13 SC which is undergoing clinical trials with the goal of obtaining approvals in 2019.