infliximab

April 6, 2016April 6, 2016

CHMP Issues Positive Opinion on Samsung Bioepis’ Flixabi, a Biosimilar Treatment for IBD

Crohn's Disease, IBD News, News, Ulcerative colitis

The Committee for Medicinal Products for Human Use (CHMP), the scientific board of European Medicines Agency, has issued a positive opinion on Samsung Bioepis’ Flixabi for the treatment of ulcerative colitis (UC) ... Read more

February 12, 2016February 12, 2016

First Biosimilar Therapy for Crohn’s Disease and Ulcerative Colitis Is Focus of FDA Meeting

Crohn's Disease, IBD News, News, Ulcerative colitis

The U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee recently met to review a biologics license application (BLA) submitted by Celltrion Inc. for its compound CT-P13, a proposed biosimilar to Remicade ... Read more

January 13, 2016January 13, 2016

IBD Patients Treated With Anti-TNF Drug Develop Skin Lesions

News

In a new study, researchers investigated the development of skin lesions and their clinical course in patients with inflammatory bowel disease (IBD) who were under anti-tumor necrosis factor (TNF) antibody ... Read more

November 6, 2015November 11, 2015

Biosimilar Infliximab IBD Drug Shown to Be as Effective and Safe as Original Therapy

News

Celltrion Healthcare recently presented positive clinical results of recent studies evaluating the efficacy and safety of switching from the original infliximab therapy (RMP) to the biosimilar infliximab Remsima® treatment in patients with ... Read more

August 26, 2015August 26, 2015

IBD Biosimilar Inflectra Approved by TGA

IBD News, News

Patient advocacy groups and the biotech industry are heralding the development and approval of biosimilars as a new day for the Inflammatory Bowel Disease’s (IBD) treatment. After the launching of the first Biosimilar ... Read more

August 17, 2015August 17, 2015

MSD Releases Statement on NICE Publication HTTA329 on Introducing Biosimilars of Infliximab

IBD News, News

Last July 2015, NICE published HTTA329 as a reference for select NHS organizations in the UK that are currently planning to join the market with their own biosimilar products for ... Read more

June 8, 2015June 8, 2015

First Infliximab Biosimilar Approved in Brazil For Crohn’s Disease

Crohn's Disease, News

The National Health Surveillance Agency (ANVISA) in Brazil has approved the commercialization of Remsima (infliximab), indicated for a series of conditions such as Crohn’s disease and ulcerative colitis, making it the first ... Read more

May 22, 2015May 22, 2015

Safety and Efficacy of Biosimilar Infliximab Treatment in IBD Patients Presented at DDW 2015

IBD News, News

Celltrion Healthcare and Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo in Norway recently presented at the Digestive Diseases Week (DDW) 2015 in Washington D.C. results from a study ... Read more

March 19, 2015March 19, 2015

Samsung Submits MAA for Remicade Biosimilar For Crohn’s Disease, Ulcerative Colitis to EMA

Crohn's Disease, News, Ulcerative colitis

Samsung Bioepis Co. Ltd. recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) regarding a biosimilar treatment for several conditions, including Crohn’s disease and ulcerative colitis. The Remicade (Infliximab) ... Read more

February 26, 2015September 28, 2016

Hospira Presents Updates on Biosimilar Inflectra for IBD at 2015 ECCO-IBD Conference

News

Recently, IBD News Today reported on how Hospira, Inc. announced the launch of Inflectra (infliximab), the first biosimilar monoclonal antibody (mAb), in major European markets. Now, the company has been invited ... Read more