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Biosimilar advances for Celltrion Healthcare Posted 13/11/2020

South Korea-based biotechnology company Celltrion Healthcare announced advances related to their infliximab, omalizumab and adalimumab biosimilars.

Subcutaneous administration of infliximab (Remsima) for IBD
Celltrion presented findings related to the use of subcutaneous infliximab (Remsima; CT-P13) in patients with inflammatory bowel disease (IBD), on 10 October 2020, at the United European Gastroenterology (UEG) Week Virtual 2020. These showed that there are benefits for patients with Crohn’s disease and ulcerative colitis (UC) in terms of efficacy and lower fecal calprotectin levels. Fecal calprotectin is a protein biomarker associated with active IBD, which includes Crohn’s and UC. Their study showed that 42 out of 54 patients (77.8%) who completed treatment up to 54 weeks achieved clinical remission. In addition, highest efficacy outcomes were visible in those who received highest infliximab exposure (> 26.7 μg/mL).

It was also shown that fecal calprotectin levels are associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients when treated subcutaneously with Remsima. Additional study findings also suggest that higher subcutaneous infliximab pre-dose levels may be associated with better clinical outcomes than intravenous infliximab administration.

This news comes after the announcement that, as a treatment for inflammatory conditions, Celltrion’s Remsima is also being investigated as a possible treatment option for COVID-19 symptoms [1].

Phase III trial of omalizumab biosimilar for asthma and hives
On 9 October 2020, Celltrion announced the start of a phase III clinical trial of its omalizumab biosimilar for the treatment of chronic idiopathic urticaria, a form of hives. The originator of this biosimilar is Xolair, an antibody biopharmaceutical sold by Genentech and Novartis that is approved for treatment of allergic asthma and idiopathic urticaria. Xolair is approved in the US, Europe and Japan and achieved global sales of over a billion dollars in 2019.

Celltrion will conduct the phase III trial in seven countries, including Korea, on 600 people with idiopathic urticaria. The company aims to complete trials and demonstrate the biosimilarity of its product with Xolair by early 2023. This follows the company’s global phase I clinical trial for safety and pharmacokinetic (PK) evaluation that began in July 2019.

Promising results for adalimumab biosimilar for rheumatoid arthritis
At the American College of Rheumatology (ACR) Convergence 2020 on 2 November 2020, Celltrion announced the presentation of new data to demonstrate the efficacy, PK and overall safety of their adalimumab biosimilar (CT-P17), for the treatment of rheumatoid arthritis patients. This is the first high concentration (100 mg/mL) citrate-free adalimumab biosimilar candidate. The company’s randomized, double-blind, phase III study carried out over 24 weeks showed that their product is equivalent to the reference in terms of safety and efficacy. The biosimilar candidate also demonstrated comparable PK and safety data with EU-approved adalimumab and US-licensed adalimumab in healthy subjects. In addition, they presented data to show that an autoinjector could be a viable administration method to a pre-filled syringe.

Celltrion submitted an application to the European Medicines Agency (EMA) for this adalimumab biosimilar in the first part of 2020 [2].
 
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biocon and Celltrion make progress in the battle against COVID-19 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 13]. Available from: www.gabionline.net/Biosimilars/News/Biocon-and-Celltrion-make-progress-in-the-battle-against-COVID-19 
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion files application with EMA for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 13]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-files-application-with-EMA-for-adalimumab-biosimilar

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