Humira

January 17, 2018

FDA to Review Sandoz’s Application for Biosimilar to Bowel Disease Therapy Humira

News

The U.S. Food and Drug Administration has agreed to review Sandoz’s application for a biosimilar to AbbVie’s bowel disease therapy Humira (adalimumab). “When patients are dealing with a chronic disease, it is imperative ... Read more

December 18, 2017December 18, 2017

Variation in Single Gene May Determine Response to Humira in IBD Patients, Study Reports

News

A single variation in the DNA sequence of a particular gene, called ATG16L1, was associated with response to Humira (adalimumab) treatment in a group of people with inflammatory bowel disease ... Read more

December 4, 2017December 4, 2017

18 Organizations Form IBD UK to Improve Crohn’s and Colitis Care Through Collaboration

News

Inflammatory bowel disease has been increasing since the 1960s, burdening not only those who live with IBD but the global healthcare system as well. That has led 18 organizations in ... Read more

November 16, 2017November 16, 2017

EU Approves Humira Biosimilar Cyltezo for Treatment of Chronic Inflammatory Diseases

News

The European Commission recently approved Cyltezo, a biosimilar to Humira (adalimumab), for the treatment of chronic inflammatory diseases in adults and children including inflammatory bowel diseases (IBDs) such as Crohn’s disease ... Read more

September 6, 2017September 6, 2017

Canada Extends Insurance Coverage of Humira for Ulcerative Colitis Patients

News

Canadian health authorities have decided to increase national coverage of Humira (adalimumab) through its federal Non-Insured Health Benefits (NIHB) program, which provides coverage to nearly one million status First Nations ... Read more

August 30, 2017August 30, 2017

FDA Approves Humira Biosimilar Cyltezo for Ulcerative Colitis, Crohn’s Disease, Other Illnesses

News

The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim‘s Cyltezo— a biosimilar of Abbvie’s Humira (adalimumab) — to treat Crohn’s disease, ulcerative colitis and a host of other diseases ranging from ... Read more

August 29, 2017August 29, 2017

European Commission Approves Biosimilar Imraldi for Crohn’s Disease and Ulcerative Colitis

News

The European Commission has approved Imraldi, an adalimumab biosimilar referencing AbbVie’s Humira — making the medication available to treat the same therapeutic indications as Humira, including Crohn’s disease, pediatric Crohn’s disease and ... Read more

June 26, 2017

EMA Committee Urges Approval of Humira Biosimilar Imraldi to Treat IBDs

News

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding on marketing authorization for Imraldi (adalimumab), a biosimilar candidate referencing Humira. The EMA ... Read more

May 24, 2017

Miraca’s InformTx Treatment Response Platform for IBD Now Includes Testing for Inflectra

News

Miraca Life Sciences‘ InformTx testing helps doctors assess the response of patients with inflammatory bowel disease (IBD) to certain drug treatments. The company has now expanded its therapeutic drug monitoring ... Read more

April 3, 2017

FDA Reports of Crohn’s Disease Treatment Side Effects Have Increased, Analysis Finds

News

Drugs used to treat Crohn’s disease and other autoimmune disorders are among those with the greatest number of reported side effects filed with the U.S. Food and Drug Administration (FDA), ... Read more