Infliximab is an inhibitor of the inflammatory molecule tumour necrosis factor-alpha (TNF-α) and is used to treat a range of conditions including rheumatoid arthritis (RA).

South Korean biotechnology company Celltrion has developed a biosimilar version that can be administered subcutaneously (the drug is typically given by intravenous [IV] infusion) named Remsima SC. The biosimilar received European marketing authorization for Remsima SC in November 2019 [1]. Now, in February 2020, the company has announced that prescriptions of Remsima SC have started in Germany and the UK.

Remsima SC is the only subcutaneous (SC) formulation of infliximab available. A spokesperson for the company said: ‘The drug offers patients with RA an alternative option to IV administration through self-injection at home in less than two minutes, reducing hospital attendance and providing patients […] with more flexibility and control over how they receive their treatment’.

The company began sales of the prescription drug in Germany in February 2020 as part of its efforts to increase sales in Europe. Germany has the largest TNF-α inhibitor market in Europe.

Remsima SC marks the first product that Celltrion is selling directly. The company is setting the price of the biosimilar higher than the first-line treatment, but lower than the second-line treatment, a so-called ‘prime-similar strategy’.

Shortly afterwards, Celltrion also announced the launch of Remsima SC in the UK, which, together with Germany, accounts for more than 30% of European sales for TNF-α inhibitors. Celltrion has signed an agreement with the UK’s National Health Service to supply the biosimilar to patients in England and Scotland.

‘The UK has a higher preference for SC over IV, which will help Remsima SC succeed in the country,’ the company said. Celltrion plans to provide nurse consultancy programmes and personalized monitoring kits that allow patients to check their anti-drug antibodies in the UK, as well as Remsimate, a mobile application dedicated to Remsima SC.

Celltrion Vice Chairman, Kim Hyeong-gi, said: ‘The company plans to recruit more than 300 employees with professional marketing capabilities for Remsima direct sales from around the world by the end of the year’.

The company plans to launch the product in Ireland and The Netherlands in the first half of 2020, expanding throughout Europe by the end of 2020.

Celltrion has also applied for the European Medicines Agency (EMA) approval of CT-P17, the biosimilar version of Humira (adalimumab), which is also a TNF-α inhibitor indicated for the treatment of conditions including RA and inflammatory bowel disease. It is given by SC injection.

‘We will do our best to obtain the go-ahead from EMA because we believe the market has high expectations of CT-P17 featuring differentiated commercial values from existing Humira biosimilars’, a company official said.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for subcutaneous infliximab biosimilar Remsima SC [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-subcutaneous-infliximab-biosimilar-Remsima-SC

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