biosimilar

April 11, 2016April 11, 2016

FDA Approves Inflectra, a Biosimilar to Remicade, to Treat Ulcerative Colitis and Crohn’s

News

Celltrion announced that the U.S. Food and Drug Administration (FDA) approved Inflectra (biosimilar infliximab) for all indications of the reference product Remicade (infliximab), marketed in the country by Janssen Biotech, Inc. ... 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

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 21, 2015August 21, 2015

Remicade Biosimilar Inflectra Now Registered in Australia for Crohn’s Disease, Ulcerative Colitis

News

Hospira, Inc. has just announced its leading monoclonal antibody (mAb) biosimilar therapy, Inflectra, is now registered in Australia as a treatment of 8 inflammatory diseases, including: rheumatoid arthritis (RA); psoriatic ... 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

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