Gastroenterology

Biosimilar Gastroenterology Roundup: October 2019

October 31st 2019

By Kelly Davio

With new research presented this month, and with new biosimilars in the pipeline that target inflammatory bowel disease (IBD), October was a notable month for biosimilars in the gastroenterology space.

After Public Drug Coverage for Infliximab, Adalimumab, Surgeries and ED Visits for CD Fell

October 29th 2019

By Allison Inserro

Article

Between 2003 to 2014, patients in Ontario, Canada, received public drug benefits for infliximab or adalimumab at a combined rate of 2.2% in 2003, rising to 18.8% of eligible patients by 2014. During that period, the prevalence of Crohn‐related hospitalizations fell 32.4%.

ACG Case Studies Report on AEs, and Their Resolution, With Biosimilar Infliximab

October 29th 2019

By Kelly Davio

Article

This week, clinicians gathered in San Antonio, Texas, for the American College of Gastroenterology (ACG)’s 2019 meeting, where a number of presentations focused on the treatment of inflammatory bowel disease. During the congress, 2 studies presented addressed adverse events (AEs) associated with—one of which was resolved by—the use of biosimilar infliximab, CT-P13 (Inflectra).

Canadian Gastroenterology Groups Issue Joint Position That Takes Aim at Nonmedical Switching

October 25th 2019

By Kelly Davio

Article

The Canadian Association of Gastroenterology and Crohn’s and Colitis Canada this week announced a joint statement on biosimilars in the treatment of inflammatory bowel disease (IBD). The paper, which is slated to appear in the Journal of the Canadian Association of Gastroenterology, recommends that patients stable on biologic treatment should not be subject to nonmedical switching, and recommends against automatic substitution of biosimilars for their references.

Pooled Analysis Underscores Safety of Biosimilar Infliximab, CT-P13, in Patients With IBD

October 24th 2019

By The Center for Biosimilars Staff

Article

During the United European Gastroenterology Week 2019, held October 29-23 in Barcelona, Spain, researchers from Celltrion presented pooled data from 3 postmarketing studies of CT-P13 in patients with inflammatory bowel disease (IBD) that underscore the safety of the biosimilar.

Switching Between 2 Biosimilars of Infliximab Does Not Impact Treatment Persistence in IBD, Study Finds

October 23rd 2019

By Kelly Davio

Article

While providers are increasingly comfortable with switching patients with inflammatory bowel disease (IBD) from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.

At UEG 2019, Data Shed Light on Monitoring of Biosimilar Adalimumab, Imraldi, in IBD

October 22nd 2019

By Kelly Davio

Article

Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti–tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology (UEG) Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.

In IBD, Celltrion's Subcutaneous Infliximab Biosimilar Proves Noninferior to Intravenous Option

October 21st 2019

By Kelly Davio

Article

During the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers presented results of a phase 1 pivotal study of a subcutaneously administered formulation of biosimilar infliximab, CT-P13 (Remsima, Inflectra), in patients with inflammatory bowel disease (IBD).

Two Studies Report Results of Vedolizumab, Adalimumab, Ustekinumab for Ulcerative Colitis

September 26th 2019

By Allison Inserro

Article

A pair of studies appearing in The New England Journal of Medicine report on 2 separate studies of biologics in patients with moderate-to-severe ulcerative colitis: One study confirms top-line results seen earlier this year in a head-to-head study of vedolizumab and adalimumab, and the other reports on the results of a single intravenous infusion of ustekinumab followed by subcutaneous maintenance injections.

AHIP Report Cites Reference Biologics as Examples of Orphan Drug Gaming

September 17th 2019

By Allison Inserro

Article

While acknowledging the role that the Orphan Drug Act had in incentivizing drug companies to develop treatments for small populations suffering from rare diseases, America’s Health Insurance Plans (AHIP) says pharmaceutical companies are using orphan drug status to create blockbuster drugs that are then used to treat other common medical conditions.