Celltrion Healthcare launch Remsima® SC in UK

Celltrion Healthcare today announced the UK launch of Remsima^® SC (infliximab), the first and only subcutaneous (SC) formulation of infliximab for the treatment of patients with rheumatoid arthritis (RA).

In the UK, more than 400,000 people have RA. It typically affects more women than men and the most common age for people to develop RA is between 40 and 60 years old. [i]

Remsima^® SC is approved in the EU for the treatment of people with RA in combination with methotrexate (MTX); in adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs), including MTX, has been inadequate; and in adult patients with severe, active and progressive disease not previously treated with MTX or other DMARDs.[ii]

The approval was based on clinical evidence including results from a study that showed switching people with RA from the intravenous (IV) formulation to the SC formulation of CT-P13 treatment at Week 30 was comparable to maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile).[iii]

Prof. Mike Ehrenstein, a Consultant Rheumatologist at UCL Hospitals in London said, “Remsima^® SC has been shown to have a similar efficacy and safety profile to CT-P13 IV. CT-P13 SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure. 

“It therefore 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 in the UK with more flexibility and control over how they receive their treatment.”

As part of Celltrion’s strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in the UK to manage sales and marketing activities for Remsima^® SC.

Matthew Eddleston, UK Commercial Lead in the Europe Business Division at Celltrion Healthcare and Vice Chair of the British Biosimilars Association (BBA), added, “We are delighted to bring the first and only subcutaneous form of infliximab to patients, NHS policy makers, clinicians, commissioners and regulators in the UK. As the first value added medicine in Celltrion’s portfolio, we are proud that this is our first product launch in the UK under our new direct sales marketing strategy. By opening an office here, Celltrion Healthcare will strengthen its presence in the UK and support the company’s further growth.”

Celltrion has also submitted a further variation to the marketing authorisation of Remsima^® SC to include the inflammatory bowel disease indication, and the approval decision is expected in mid-2020.

Celltrion Healthcare has an extensive global network that spans more than 110 different countries. The launch of Remsima^® SC in the UK follows the recent launch of the treatment in Germany.

[i] National Rheumatoid Arthritis Society. What is rheumatoid arthritis? Available at: https://www.nras.org.uk/what-is-ra-article [Last accessed February 2020].

[ii] European Medicines Agency Summary of Product Characteristics (SmPC). Remsima SC^®.

[iii] Westhovens R, Wiland P, Zawadzki M et al. Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). Available at: https://acrabstracts.org/abstract/efficacy-and-safety-of-a-novel-subcutaneous-formulation-of-ct-p13-over-the-1-year-treatment-period-and-after-switching-from-intravenous-ct-p13-in-patients-with-active-rheumatoid-arthritis-results-fro/. [Last accessed February 2020].