Celltrion approved for domestic sales of 'Remshima SC' drug for autoimmune diseases
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Press Release[/caption]
European EMA license last November??To pioneer market with the first infliximab SC formulation in Korea
-Prior approval for RA indications.?Secure IBD indications and introduce them to the domestic market
[February 26, 2019] Celltrion announced on November 26 that its own antibody biopharmaceutical, 'Ramshima SC', has been approved for marketing in Korea by the Ministry of Food and Drug Safety (KFDA).
Celltrion is the first infliximab SC formulation to change the formulation of the conventional intravenous (IV) lambda injection into subcutaneous injection (SC) to gain a strong competitive edge in the market of TNF-a inhibitors (autoimmune diseases). In November last year, the company obtained sales approval from the European Medicines Agency (EMA) and made its debut in the European market starting this month in Germany.
The indication approved by the Food and Drug Administration is RA (Rheumatoid arthritis) indication, and Celltrion plans to receive additional indications within the year through the change permit procedure to add IBD (Inflammatory bowel disease) indication.?Ramshima SC will be introduced to the domestic market after completion of the permit for the addition of IBD indications.
Celltrion has recently filed an application for a Ramshima SC license in Canada to enter the North American market and plans to supply it throughout Canada through Celltrion Healthcare's direct sales network.?In addition, in the US, the world's largest biopharmaceutical market, Ramshima SC is recognized as a 'new drug', exempting from phase 1 and 2 clinical trials, and currently undergoing phase 3 clinical trials smoothly.?Celltrion aims to license the US Food and Drug Administration (FDA) in 2022.
An official of Celltrion said, "With the approval of the Ramshima SC Food and Drug Administration, Celltrion has a strong portfolio in the autoimmune disease treatment market in Korea." "Remshima has proven its efficacy and safety through clinical data disclosure at leading overseas conferences. We will do our best to secure indications for IBD so that SC can be introduced to Korean patients early. ?
Meanwhile, according to the IQVIA report of the market research institute (as of the first half of 2019), Ramshima has expanded its market share to 36% in the domestic market, surpassing the replacement rate of the original drug market by 40%.?Trouxima and Hejuma are also leading the domestic biosimilar market by securing market share of 20% and 22% respectively in the first half of 2019.
Press Release[/caption]
European EMA license last November??To pioneer market with the first infliximab SC formulation in Korea
-Prior approval for RA indications.?Secure IBD indications and introduce them to the domestic market
[February 26, 2019] Celltrion announced on November 26 that its own antibody biopharmaceutical, 'Ramshima SC', has been approved for marketing in Korea by the Ministry of Food and Drug Safety (KFDA).
Celltrion is the first infliximab SC formulation to change the formulation of the conventional intravenous (IV) lambda injection into subcutaneous injection (SC) to gain a strong competitive edge in the market of TNF-a inhibitors (autoimmune diseases). In November last year, the company obtained sales approval from the European Medicines Agency (EMA) and made its debut in the European market starting this month in Germany.
The indication approved by the Food and Drug Administration is RA (Rheumatoid arthritis) indication, and Celltrion plans to receive additional indications within the year through the change permit procedure to add IBD (Inflammatory bowel disease) indication.?Ramshima SC will be introduced to the domestic market after completion of the permit for the addition of IBD indications.
Celltrion has recently filed an application for a Ramshima SC license in Canada to enter the North American market and plans to supply it throughout Canada through Celltrion Healthcare's direct sales network.?In addition, in the US, the world's largest biopharmaceutical market, Ramshima SC is recognized as a 'new drug', exempting from phase 1 and 2 clinical trials, and currently undergoing phase 3 clinical trials smoothly.?Celltrion aims to license the US Food and Drug Administration (FDA) in 2022.
An official of Celltrion said, "With the approval of the Ramshima SC Food and Drug Administration, Celltrion has a strong portfolio in the autoimmune disease treatment market in Korea." "Remshima has proven its efficacy and safety through clinical data disclosure at leading overseas conferences. We will do our best to secure indications for IBD so that SC can be introduced to Korean patients early. ?
Meanwhile, according to the IQVIA report of the market research institute (as of the first half of 2019), Ramshima has expanded its market share to 36% in the domestic market, surpassing the replacement rate of the original drug market by 40%.?Trouxima and Hejuma are also leading the domestic biosimilar market by securing market share of 20% and 22% respectively in the first half of 2019.
