Celltrion's Remsima SC scores 'off-label' prescription success in UK
This undated photo, provided by Celltrion Inc., shows its drug Remsima SC. Korea Times file
By Kim Yoo-chul
Celltrion Healthcare's Remsima SC has been prescribed “off-label” to IBD patients with success in the United Kingdom, according to industry officials, Tuesday.
“Off-label” use means the medication is being used for a medical condition, age group, dosage or route of administration not officially approved by a drug regulatory agency. The approval had originally been expected sometime in mid-2020.
“Celltrion Healthcare-developed Remsima SC was successfully prescribed for six patients with inflammatory bowel disease (IBD) in the U.K. for the first time in the industry,” one industry official said.
The achievement came after health officials are advising people to stay at home amid the spread of COVID-19, raising some worries over patients who have autoimmune diseases and receive proper and on-time medical treatment via infusions. Because of the pandemic, there are some cases in which physicians prescribe medicines off-label.
As at-risk IBD patients may find it difficult to visit their usual treatment sites, Remsima SC becoming available to them as soon as possible stands to help patients continue their treatment offsite.
Recently, Celltrion announced the successful U.K. launch of Remsima SC, the first and only subcutaneous (SC) formulation of infliximab for treatment of patients with rheumatoid arthritis. Remsima SC was approved in the EU for treatment for people with the crippling autoimmune disorder. Officials said the approval was based on clinical evidence including results from studies on switching rheumatoid patients from the intravenous (IV) formulation to the SC formulation, they said.
In the U.K., some 400,000 people are known to be suffering from rheumatoid arthritis. It usually affects women more than men and the most common age for people to develop RA is between 40 and 60, according to reports.
Unlike IV formulation, the SC formulation has advantages that make home administration possible. The Korean biopharmaceutical firm-developed Remsima SC is considered as the only viable SC formulation of its kind. The ongoing pandemic helped Celltrion Healthcare win the approval for the off-label usage earlier than expected. Public healthcare doesn't cover the usage, according to officials.
“The latest Celltrion Healthcare case is understood as the decision to address risk factors for the needy during the pandemic. It remains to be seen whether the early advance of Remsima SC would provide a fresh impetus for the SC formulation's market expansion,” another industry official added.
On a related note, facing the pandemic, Johns Hopkins Medicine IBD Center also recently has put together IBD patient guidance advising them to continue their medications as prescribed.
In an effort to expand its European sales network, Celltrion Healthcare has recently established an entity in the U.K. to mainly manage sales and marketing activities for Remsima SC.