biosimilar

August 6, 2018August 6, 2018

CHMP Favors Approval of Hulio, Biosimilar to Humira, to Treat IBD Patients in EU

News

Hulio, a biosimilar to Humira (adalimumab), has been given a favorable opinion by the Committee for Medicinal Products for Human Use (CHMP) to treat a number of inflammatory diseases in the EU — including ... Read more

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

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

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

February 23, 2017

Biosimilar Inflectra Matches Remicade as Crohn’s Treatment, Trial Results Show

News

The biosimilar therapy Inflectra (infliximab CT-P13) is as good a treatment as Remicade (infliximab) for those with moderate-to-severe Crohn’s disease (CD), according to the results of a clinical trial. Pfizer and Celltrion Healthcare, ... Read more

September 27, 2016

U.S. FDA Approves Biosimilar Amjevita for Multiple Inflammatory Diseases

News

The Division of Drug Information at the U.S. Food and Drug Administration (FDA) has announced its approval of Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for the treatment of multiple ... Read more

June 9, 2016August 12, 2016

IBD Study Shows Celltrion’s Inflectra, Biosimilar of Infliximab, Is Safe and Effective

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

Celltrion’s Inflectra, a biosimilar version of infliximab (Remicade), is both safe and effective in patients with inflammatory bowel disease (IBD), a recent study reported at the Digestive Disease Week 2016 meeting ... Read more

April 13, 2016September 28, 2016

Celltrion’s Inflectra, a Biosimilar to Treat Ulcerative Colitis and Crohn’s Disease, Gets FDA Approval

News

Celltrion recently announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of its Inflectra (biosimilar infliximab) product for all indications of the reference product, ... Read more