The first infliximab hypodermic injection in the world! Remsima SC of celltrion is approved in the EU!

November 27, 2019 / BIOON / -- South Korean biopharmaceutical giant celltrion recently announced that the European Commission (EC) has approved remsima SC (ct-p13 SC, infliximab biological analogue) for the treatment of rheumatoid arthritis (RA) patients Remsima SC is a subcutaneous injection type of ct-p13, a biological analogue of infliximab from celltrion In particular, remsima SC is the first infliximab product for subcutaneous injection in the world This new formulation will provide an alternative drug delivery option for doctors and patients in Europe Remima SC is suitable for: (1) combination of methotrexate (MTX) for the active RA adult patients with insufficient response to disease modified anti rheumatic drugs (DMARD), including MTX; (2) for the severe, active, progressive RA adult patients who have not received MTX or other DMARD treatment before This approval is based on the results of a clinical study on RA, which showed that the efficacy of changing the treatment of RA patients from ct-p13 intravenous (IV) preparation to ct-p13 subcutaneous (SC) preparation at the 30th week of treatment is comparable to that of continuing to maintain ct-p13 SC treatment at the 54th week (safety to the 64th week) Professor Rene westhovens, a rheumatologist at the University of Leuven hospital in Belgium, commented: "the approval of remsima SC in Europe will give patients the opportunity to inject themselves, which will enable them to better control their treatment Remima SC has shown stable efficacy, and compared with patients treated with ct-p13 IV, patients treated with remima SC produce fewer anti drug antibodies, which can improve the effectiveness of the treatment " With the launch of this new infliximab, patients can now be treated with more personalized and convenient treatment options Reimsima SC can be injected by patients themselves, which may significantly reduce hospital visits and save the time usually required for hospital intravenous treatment Celltrion has also submitted further changes to the European Drug Administration (EMA) on the marketing authorisation of remsima SC to extend it to inflammatory bowel disease, which is expected to make an approval decision by mid-2020 At present, celltrion has applied for patent protection to remsima SC in about 100 countries (including the United States, Europe and Asia) until 2038 "The development of remsima SC shows that celltrion is not only a biopharmaceutical company, but also an innovative company dedicated to the development of new solutions, such as infliximab biopharmaceutical subcutaneous preparations," said hyung kikim, vice chairman of celltrion We have developed cost-effective and patient-centered therapies that allow more patients to access biologics with proven efficacy and safety Celltrion has expanded its business to enhance its presence in key European markets Celltrion is expected to launch reimsima SC in Europe in the first quarter of 2020 " Source: celltrion healthcare receives EU marketing authorization for world's first subcutaneous formula of infliximab, remsima SC Gamma , for thetreatment of people with rheumatoid arthritis