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Europe approves first subcutaneous version of biosimilar infliximab

Published on 26/11/19 at 11:30am

The European Commission has chosen to authorise Celltrion Healthcare’s Remsima SC, a biosimilar of infliximab and the first subcutaneous formulation of the therapy, it has emerged.

The therapy was approved in combination with methotrexate (MTX) for the treatment of active rheumatoid arthritis in adult patients who have seen inadequate response with disease-modifying anti-rheumatic drugs (DMARDs), including MTX, and additionally in patients with severe, active and progressive forms of the disease who have not been previously treated with MTX or other DMARDs.

The product can be self-injected by patients, which Celltrion argues could “significantly reduce” hospital visits and free up time traditionally taken up by administered IV treatment.

The approval was based on clinical data demonstrating that switching from the intravenous (IV) formulation of biosimilar infliximab to the subcutaneous (SC) formulation at 30 weeks of treatment produced comparable efficacy to maintaining the IV formulation up to Week 54.

“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,” commented 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 also announced that it has applied for patent protection on the product until 2038 in around 100 countries across Europe, Asia and the US.

Matt Fellows

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