Celltrion’s Remsima SC Will No Longer Need IV Loading
EMA Committee Endorses Direct Subcutaneous Use Of Infliximab Biosimilar
Celltrion has received an endorsement from the European Medicines Agency that means that its Remsima SC subcutaneous formulation of infliximab can be used directly in rheumatoid arthritis patients, without the need for intravenous loading first.
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Health Canada has approved Celltrion’s subcutaneous version of Remsima for rheumatoid arthritis, as Celltrion plans to expand indications for the infliximab biosimilar to allow it to also treat inflammatory bowel disease. The company has also established an offshoot in Canada that will allow it to sell Remsima SC directly.
Celltrion is capitalizing on the earlier strength of its intravenous Remsima formulation to make waves with its innovative subcutaneous version, according to the results of a new study sampling nearly 250 gastroenterologists in EU5 countries.
South Korea’s Celltrion has partnered with oral drug delivery specialist Intract Pharma for the formulation of oral infliximab for the treatment of inflammatory bowel disease. Celltrion has also reported year-on-year and quarter-on-quarter growth in sales, along with plans to grow in the US market.