EU Approves More Convenient Formulation of Remsima

EU Approves More Convenient Formulation of Remsima
The European Commission has approved an under-the-skin injectable formulation of Remsima (infliximab) to treat patients with the two most common forms of inflammatory bowel disease (IBD) — ulcerative colitis and Crohn's disease. Celltrion Healthcare plans to make its subcutaneous formulation, referred to as Remsima SC, available to patients in the EU as quickly as possible. The company also anticipates that it will be approved in 97 countries worldwide. Apart from IBD, Remsima SC has also been approved for the treatment of ankylosing spondylitis, psoriatic arthritis, and psoriasis in the EU. “We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option,” Hyoung-Ki Kim, vice chairman of Celltrion, said in a press release. “We will do our best to make Remsima SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.” One major advantage of Remsima SC is a significantly shorter time to administer the treatment compared to the previously-approved intravenous (injected into the blood stream) formulation, called Remsima IV. Remsima SC takes two to five minutes to be administered, whereas Remsima IV requires a two-hour infusion process, followed by an additional one to two hours of patient monitoring. This convenience is particularly relevant during the COVID-19 pandemic, as a reduction in the time spent administering a treatment could ultimately reduce the risk of viral transmission. Infliximab, the active ingredient in Remsima, is a monoclonal antibody that binds to and reduces the activity of a protein call
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