Celltrion received a 'recommendation for license approval' from the Committee for Medical Products for Human Use (CHMP) under the European Medicines Agency (EMA) on June 25 for additional application for indication of the world's first Infliximab subcutaneous (SC) injection drug 'Remsima SC.'
The CHMP, which has issued recommendations for approval of additional licenses for Remsima SC indications, is an organization that presents opinions on whether to grant permission to EMA based on the results of scientific evaluation of medicines.
Given that final approval by the European Commission comes within one to three months of the CHMP's 'license approval recommendation', Remsima SC will soon be the first Infliximab SC formulation to obtain all adult adaptations of the existing Infliximab intravenous (IV) type.
For prompt approval of Remsima SC, Celltrion has been pushing for a strategy to first obtain EMA approval for Rheumatoid Arthritis (RA) indications in November last year, and then expand it to another major indication, Inflammatory Bowel Disease (IBD).
With this CHMP approval recommendation, Remsima SC became the first SC-type product to enter the entire Infliximab market, ranging from rheumatoid arthritis to adult inflammatory bowel disease. The indications recommended for approval this time include Crohn's disease, ulcerative colitis, cataracts, psoriasis arthritis and psoriasis for adults.
Remsima SC is expected to be sold as the first complete Infliximab SC formulation in 31 countries in Europe after obtaining final approval from the EC soon.
If it wins the European approval, it plans to carry out approval procedures in 97 countries (including 31 European countries) around the world within this year based on the same clinical results.
Further clinical trials are also underway in the United States and Japan, as Remsima SC is taking steps to approve new drugs for the shortest period of time.
Through a leading academic conference, Celltrion confirmed the excellence of Infliximab in IBD indication and also proved its validity and safety against IV formulation. In addition, hypodermic injection formulation, which maximizes patient convenience, is expected to act as another treatment option for patients, increasing demand.
In particular, Celltrion Healthcare, which is conducting global distribution and marketing of Remsima SC, plans to actively expand its IBD market share in the early stages, highlighting the advantages of not having to visit hospitals in the event of COVID-19 infection, in addition to the characteristics of SC formulation, which adds convenience to Infliximab, which has proven medical efficacy.
"We expect to further strengthen our position in the global autoimmune disease treatment market in the future as Ramsima SC's additional approval for indications becomes visible," an official of Celltrion said. "Since Remsima SC's main ingredient, Infliximab, is considered the most preferred ingredient by experts in inflammatory bowel diseases, we expect a remarkable market share in the future."
