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 18.4bn in 2017, 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.
Headquartered in Incheon, Korea, Celltrion is a biopharmaceutical company, specialising in research, development and manufacture of biosimilar and innovative drugs.
The company 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.
NeoImmuneTech names new president and chief executive officer
BenevolentAI reports positive Phase Ia safety and pharmacokinetic data for BEN-8744
Thermo Fisher Scientific unveils CorEvitas registry for generalized pustular psoriasis
Nektar Therapeutics commences Phase 2b rezpegaldesleukin clinical trial for alopecia areata
Innovent Biologics doses first participant in first-in-human phase one clinical trial of IBI3002
Ananda Developments secures CBD Drug Supply Agreement for endometriosis clinical trial
Trellus Health secures agreement with major US health plan for IBD management
argenx receives FDA priority review for VYVGART Hytrulo in CIDP
AffaMed Therapeutics' DEXTENZA NDA accepted by Singapore regulator
AbbVie showcases gastroenterology portfolio at ECCO Congress
Japan approves Sanofi's Dupixent for chronic spontaneous urticaria
Ono partners with Shattuck Labs for bifunctional fusion proteins