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The company noted that Professor Jorgen Jahnsen at the University of Oslo's Department of Gastroenterology in Norway has shown via clinical trial that it was safe to switch from the original Remicade to Celltrion's biosimilar. He presented his findings at the United European Gastroenterology Week conference in Vienna, Austria last Tuesday.
"What this proves is its interchangeability with the original medicine," said a company spokesperson.
"This would further establish the biosimilar's dominance in Norway where its market share stands at around 90 percent."
Remsima is the world's first biosimilar monoclonal antibody, and gained its approval for the European market from the European Medicines Agency and the European Commission in 2013. Soon after, Celltrion entered a state bidding competition and won the right to sell in Norway.
The University of Oslo's Gastroenterology conducted clinical tests on some 500 patients with disorders such as rheumatoid arthritis, ulcerative colitis and ankylosing spondylitis, who were being treated with Remicade, for six months, Celltrion said.
In an academic research paper "Switching from Remicade to Remsima is safe and feasible: a prospective, open-label study," authors from the University of Oslo's Department of Gastroenterology, Oslo University Hospital Faculty of Medicine, and Oslo and Akershus University College of Applied Sciences wrote, "Our study demonstrated that switching from Remicade to Remsima was feasible and with few adverse events, including very limited antidrug antibody formation and loss of response."
In their test results, they further said, "A low number of adverse events were observed. No change in disease activity, C-reactive protein, haemoglobin, faecal calprotectin, Infliximab dose and interval or p-Infliximab was detected. Three patients developed new detectable antidrug antibodies."
Global sales of J&J's blockbuster Remicade drug stand at around $7 billion, and giant pharmaceutical companies such as Pfizer have been challenging J&J in the arthritis medicine sector. Pfizer recently won a patent dispute with J&J in the US, enabling Pfizer to market its biosimilar Infectra, which will be produced by Celltrion. Remsima for the European market and Infectra for the US market are the same drug that uses different brand names. Pfizer will be launching Infectra in the US next month, according to Pfizer and Celltrion.
Celltrion declined to disclose its sales of its Remsima biosimilar. However, according to the Korea Trade Statistics Promotion Institute, the biotech company has exported the biosimilar drug worth some 1 trillion over the last four years.
Celltrion is currently the No. 1 company listed on the tech-heavy Kosdaq, with its market cap increasing more than 700 times over the last decade, according to CEO Score, a business information service provider. Its market cap stands at 12.3 trillion won ($11 billion).
