Celltrion said it has completed phase 3 clinical trial for Remsima SC, the subcutaneous (SC) version of Remsima, an infliximab biosimilar that treats diseases such as Crohn’s disease, adult ulcerative colitis, and rheumatic arthritis.
The company is analyzing its clinical data as it is in the final stage of applying for a marketing authorization application to the European Medicines Agency (EMA). The company plans to submit the form in the second half of this year.
Celltrion has developed Remsima SC to obtain a competitive edge in the TNF-α inhibitor market along with its existing intravenous (IV) formulation of Remsima. Since May 2016, Celltrion has conducted phase 1 and 3 clinical trials to confirm the safety, pharmacokinetic and efficacy of Remsima SC.
The company expects that the new product will increase convenience for the patients as unlike conventional intravenous formulations that require patients to visit hospitals, patients can inject Remsima SC by themselves.
Celltrion expects that the potential demand base will include patients satisfied with the therapeutic effects of infliximab and yet want to administer the drug by themselves. The company also believes that patients who use Abbvie’s Humira and Amgen’s Enbrel as potential clients
“In the global TNF-α inhibitor market, the sales for subcutaneous injection formulations amounts to 30 trillion won ($27.6 billion),” a company official said. “Celltrion plans to lead the TNF-α inhibitor market with Remsima, Remsima SC and CT-P17.”
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