Celltrion said on July 27 that the European Commission additionally approved Remsima SC's inflammatory bowel disease (IBD) and other indications on July 24 (local time).
The approval was made about a month after receiving a "recommendation for approval of permission" for additional applications for Remsima SC indications from the Drug Use Advisory Committee under the European Medicines Agency on June 25. It is an unusual approval process that took place under the COVID-19.
Until now, medical staff who have locally prescribed Infliximab IV formulation to IBD patients have been waiting for Remsima SC's prompt approval, submitting a petition to the licensing agency that Infliximab SC formulation will help increase medical convenience in the COVID-19 situation.
With the approval, Remsima SC has become the world's first Infliximab SC formulation, which has acquired all adult indications of the existing IV formulation from rheumatoid arthritis to IBD, Crohn disease, ulcerative colitis, cataractitis, psoriasis and psoriasis.
In the IBD indications approved this time, medical staff's preference for Remsima SC prescriptions is high, and it is expected that they will enter the market quickly.
Among the world's autoimmune disease treatment markets, the market size of tumor necrosis inhibitor, which Remsima SC belongs to, was about $46.8 billion (about 55 trillion won) based on last year's prescription.
Of the total, inflammatory bowel disease accounts for about 30 percent of the total market, or $14 billion (about 17 trillion won).
Remsima SC is expected to be sold in 31 European countries in the near future as the first complete Infliximab SC formulation.
With the European approval, the company 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. In addition, Remsima SC is also taking steps to get new drug licenses in the United States and Japan for the shortest period of time.
In February this year, Celltrion Healthcare began to sell Remsima SC to other European countries, including Britain, the Netherlands and Germany.
"The demand for infliximab SC formulation will be increased further in the changed medical environment by enhancing the convenience of patients and medical staff who are unable to visit hospitals amid the spread of the Corona 19 virus," said an official from Celltrion. "We will achieve sales of more than 10 trillion won in the global autoimmune disease treatment market reaching 55 trillion won and make it a global blockbuster product."
On the other hand, the argument that autoimmune diseases drugs such as Remsima SC should be considered in the treatment of COVID-19 is gaining momentum. In April, Dr. Marc Feldmann of the University of Oxford in England published a paper in the journal that research on the prescription of inhibitors for tumor necrosis factor as a COVID-19 treatment should be urgently carried out.
According to the paper, tumor necrosis factors exist in the blood and tissues of patients with COVID-19. This causes a cytokine storm that amplifies inflammation in the lungs, worsening the condition of patients with COVID-19.
Therefore, it was argued that the most suitable inhibitor for tumor necrosis targeting TNF is the infliximab, which has been prescribed for more than 20 years, and that it is likely to be effective.
Based on this, Dr. Feldmann and Birmingham University Hospital are carrying out clinical trials to confirm the treatment effect of "Ramsima" on COVID-19.
