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Tuesday 26 Nov 2019 , 10:14 am

Celltrion Healthcare Receives EU Marketing Authorisation Subcutaneous Formulation of Infliximab, Remsima SC

European Union (EU) marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (IV) version of CT-P13 in people with active rheumatoid arthritis (RA).
By SIN Bureau
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Celltrion Healthcare announced that the European Commission has approved Remsima SC (CT-P13 SC, biosimilar infliximab) for patients with RA. Remsima SC is the world’s first subcutaneous formulation of infliximab.

Remsima SC is approved in the EU for the treatment of people with rheumatoid arthritis 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.

The approval is based on clinical evidence including results from a study that showed switching people with RA from the intravenous (IV) formulation to the subcutaneous (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). The study was presented at this year’s American College of Rheumatology Congress.

“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”, said Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium. “Remsima SC has been shown to have a stable potency, and patients with RA on Remsima SC develop fewer anti-drug antibodies - which can improve the effectiveness of a treatment - compared with those on CT-P13 IV.”

With the availability of the novel formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima SC can be injected by patients themselves, which has the potential to significantly reduce hospital visits, as well as save time normally required for hospital-administered IV treatment.

Celltrion has also submitted a further variation to the marketing authorization of Remsima SC to extend the indication to inflammatory bowel disease and the approval decision is expected in mid-2020.

“The development of Remsima SC demonstrates that Celltrion Healthcare is not just a biosimilar company, it is also an innovative company that strives for novel solutions such as the SC formulation of biosimilar infliximab. We develop cost-effective and patient-centered treatments to enable more patients to gain access to biologics that have proven efficacy and safety profiles,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “Celltrion Healthcare has expanded its business operations to strengthen the company’s presence in the major European markets. Celltrion expects to launch Remsima SC across Europe in the first quarter of 2020.”

Celltrion has applied for patent protection, until 2038, for Remsima SC in approximately 100 countries throughout the US, Europe and Asia.




Neha Mule

Neha writes articles on sectors including medicine, food, materials, and science & technology. A qualified statistician, she has the ability to observe and analyze the trends in global markets and write compelling articles that help CXOs in decision making. She is a bookworm and loves to read fiction, lifestyle, science and technology. Neha comes with 6 years of experience in content writing and editing that involves blog writing, preparation of study materials and OERs.

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