Celltrion gets EMA nod for subcutaneous infliximab biosimilar

Remsima SC is the subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13, which is indicated for the treatment of eight autoimmune diseases, including rheumatoid arthritis (RA), and was approved in the EU under the trade name Remsima in September 2013.

The biosimilar product was also approved by the US Food and Drug Administration (FDA) in April 2016, under the trade name Inflectra. As of November 2019, CT-P13 is approved in over 89 countries including the US, Canada, Japan and throughout Europe. 

The first step towards the European approval of the subcutaneous version of the product, Remsima SC, was taken in September 2019, when Celltrion received a positive opinion​ by the European Medicines Agency (EMA). 

Subcutaneous administration

Remsima SC will be available under three administration options; via a pre-filled pen (auto injector), pre-filled syringe and pre-filled syringe with needle safeguard. 

According to the company, the subcutaneous formulation has the potential to enhance treatment options for the use of infliximab biosimilar, by providing high consistency in drug exposure, as well as a convenient method of administration.

Rene Westhovens, a rheumatologist professor at the University Hospitals KU Leuven in Belgium, commented that the approval of Remsima SC in Europe “gives patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment.''​

Westhovens added that patients on the subcutaneous version “develop fewer anti-drug antibodies, which can improve the effectiveness of a treatment,”​ compared to those on the intravenous version of the drug.

The approval refers to three indications of the drug:

• For the treatment of people with RA in combination with methotrexate
• In adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs) has been inadequate
• In adult patients with severe, active and progressive disease not previously treated with MTX or other DMARDs

Celltrion has also submitted a further variation to the marketing authorization of the product, aiming to extend the indication to inflammatory bowel disease, with the response of the EMA expected in mid-2020.

The approval came after Phase I/III clinical studies showed that switching patients with RA from the intravenous to the subcutaneous formulation of CT-P13 treatment at week 30 was comparable to maintaining CT-P13 up to week 54.