Celltrion files application with EMA for adalimumab biosimilar

Biosimilars/News | Posted 08/05/2020 post-comment0 Post your comment

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

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Adalimumab is used to treat a wide range of auto-immune conditions, including various forms of arthritis, inflammatory bowel disease and psoriasis. It is administered by subcutaneous injection and works by inhibiting the inflammatory cytokine tumour necrosis factor alpha (TNF-α). The originator biological is sold by AbbVie under the trade name Humira, which made global sales over US$19 billion in 2019.

South Korean firm Celltrion, who has recently launched infliximab biosimilars in the UK [1] and trastuzumab biosimilars in the US, has filed an application with EMA for a biosimilar version of the drug, currently known as CT-P17.

The submission was made on 6 March 2020 and included clinical data on all indications for Humira, including rheumatoid arthritis, ulcerative colitis and psoriasis. Celltrion plans to launch the biosimilar onto the European market as soon as EMA completes its licensing process, which typically takes about one year.

‘We completed our application for EMA license for CT-P17 following Remsima SC, which was approved for EMA sales in November 2019, and are making preparations to expand the TNF-α inhibitor market without a hitch,’ said a Celltrion official.

‘Since we believe that the market expectations are high, and we will do our best to obtain EMA approval for early release since it is a product that was developed with differentiated marketability from previous Humira biosimilars.’

The company has created a potent formulation and removed citrate from the preparation to reduce pain following injection.

The company also plans to complete clinical trials for biosimilars to Avastin (bevacizumab), a treatment for a number of cancers, and Xolair (omalizumab), an anti-allergy drug, as part of plans to release a new biosimilar each year until 2030 [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Celltrion launches infliximab biosimilar Remsima SC in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 8]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-launches-infliximab-biosimilar-Remsima-SC-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion to build facility in China and increase new drug output [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 8]. Available from: www.gabionline.net/Pharma-News/Celltrion-to-build-facility-in-China-and-increase-new-drug-output

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Source: Korea Biomed, Korea Herald, Korea Times

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