Celltrion applies for FDA approval for Remsima SC

The autoimmune disease treatment has seen positive results from a global phase 3 clinical trial

Celltrion's Remsima
Celltrion's Remsima
Jae-Young Han 1
2022-12-23 13:26:23 jyhan@hankyung.com
Bio & Pharma

Celltrion Ltd. said on Friday it had applied the previous day for permission from the US Food and Drug Administration (FDA) for Remsima SC, an autoimmune disease treatment.

Remsima SC (infliximab) is a self-injectable drug developed as a subcutaneous injection formulation.

A Celltrion official said it applied to the FDA based on results confirming the efficacy and safety of the global phase 3 clinical trial for ulcerative colitis and Crohn's disease.

"The influence of Remsima SC is rapidly increasing with a market share of more than 12% in Europe, where it entered the market earlier, thanks to its rapid dosing effect and convenience of formulation," said a Celltrion official.

"Once it secures new drug status in the US, it will further strengthen the position of the Remsima family and provide more patients with high-quality drug treatment opportunities," he added.

Write to Jae-Young Han at jyhan@hankyung.com
#Celltrion #Remsima SC #infliximab #US Food and Drug Administration #korea celltrion fda remsima sc

Celltrion to seek FDA approval for sale of Remsima SC by year-end

Celltrion to seek FDA approval for sale of Remsima SC by year-end

Remsima SC by Celltrion (Courtesy of Celltrion) Celltrion Inc. said it has confirmed the effectiveness and safety of Remsima SC in its third-phase global clinical trials, conducted on 438 patients of ulcerative colitis and 343 Crohn's disease patients.The South Korean pharmaceutical company cla

Celltrion wins trial against Regeneron for US patent lawsuit over biosimilar

Celltrion wins trial against Regeneron for US patent lawsuit over biosimilar

An exterior of the Celltrion plant complex in Seoul South Korean biopharmaceutical company Celltrion Inc. announced Friday that it won its first trial against New York-based biotech giant Regeneron Pharmaceuticals, Inc. regarding two patents. This lawsuit is related to the US patents for t

Celltrion's Q3 earnings boosted by Remsima sales in Europe

Celltrion's Q3 earnings boosted by Remsima sales in Europe

(Courtesy of Celltrion) South Korean biopharmaceutical giant Celltrion Inc. announced 654.6 billion won ($478.2 million) in revenue and 213.8 billion won in operating profit on a consolidated basis during the third quarter, the company said in a preliminary report on Nov. 9.If realized, the fig

Celltrion targets digital healthcare sector with app

Celltrion targets digital healthcare sector with app

Celltrion's headquarters in Incheon, South Korea (Courtesy of Yonhap) Celltrion Inc., South Korea’s biopharmaceutical giant, made a foray into the digital healthcare sector for its future growth by launching a smartphone application for irritable bowel syndrome (IBS).The disorder affectin
(* comment hide *}