[Photo provided by Celltrion]
The European Commission (EC) has granted marketing authorization for Celltrion’s Remsima SC, the world’s first subcutaneous infliximab biosimilar, for inflammatory bowel disease (IBD), the Korean company said on Monday.
The EC marketing authorization came earlier than expected after a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in June.
Shares of Celltrion finished 0.16 percent higher at 317,500 won on Tuesday.
The company said the rapid approval was affected by strong recommendations from local IBD physicians who have said the SC formulation will be greatly helpful to patient convenience amid the COVID-19 pandemic.
With the approval, Remsima SC now includes all approved indications for the intravenous form in adult patients such as IBD, Crohn disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Remsima SC will soon be available as the industry’s first complete infliximab SC form in 31 countries in Europe. Based on the latest marketing authorization, Celltrion said it will kick off approval processes in 97 countries worldwide within this year. The new product is currently under regulatory review and clinical trials in the US and Japan with a goal of completing approval in the shortest period.
By Kim Si-gyun and Minu Kim
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