Celltrion Enters into Phases 1 and 3 Clinical Trials for the Adalimumab Biosimilar 'CT-P17'

• Celltrion is set to develop CT-P17 as a high-concentration formulation, differentiating it from competitive biosimilars
• A strategy to diversify TNF-α inhibitor products such as Remsima^® and CT-P13 SC to maximize its market share
• Conducting phase 1 and phase 3 clinical studies simultaneously in 75 sites in eight nations including the U.K. with the schedule of completing the project by 2020

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion (KRX:068270) 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. And Celltrion also conducts global phase 3 clinical trials in about 75 sites in eight nations in European region from August 2018. It aims to complete phase 3 clinical trials by 2020.

The 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 USD 18.4 billion in 2017,¹ making it the global largest-selling blockbuster medicine.

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-α inhibitor biosimilar markets under the strategy of diversifying its TNF-α 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.

¹ Abbvie 2017 Annual Report
² IQVIA 2017 data

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.