Gastroenterology

Adalimumab and Originator and Biosimilar Infliximab Have Widest Coverage for UC, CD

April 24th 2019

By Kelly Davio

Access to therapy for ulcerative colitis (UC) and Crohn disease (CD) may not be consistent with treatment guidelines because of payer policies that do not concur with the American Gastroenterological Association clinical pathways for the treatment of inflammatory bowel disease.

Consensus Report Calls for More Research Into Biosimilars and the Nocebo Effect

April 2nd 2019

By Kelly Davio

Article

A new consensus report calls the nocebo effect underrecognized in the area of biosimilars and says that more research is needed on this important topic.

Head-to-Head Study Shows CT-P13 Is Noninferior to Reference Infliximab in CD

April 1st 2019

By Kelly Davio

Article

Approval of biosimilars in indications for which they were not studied directly in phase 3 clinical trials relies on the extrapolation of indications, a concept that is scientifically justified but, nevertheless, has generated some concerns among clinicians. In the case of biosimilar infliximab CT-P13 (Inflectra, Remsima), some gastroenterologists have voiced a lack of confidence in the biosimilar for the treatment of inflammatory bowel disease, including Crohn disease (CD) and ulcerative colitis. Now, head-to-head study, published in The Lancet, has produced data that may help allay those worries.

Biosimilars Benefit Patients With Expanded Access, but Physicians Still Need Education

March 29th 2019

By Kelly Davio

Article

Patient access to treatment has improved in many countries since the advent of biosimilars, where access to biologic treatments is variable among nations and faces restrictions based on limitations to healthcare resources. During the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of healthcare providers discussed this expanded access as well as other benefits that accrue to patients when biosimilars generate competition in the biologics market. They also considered lingering hurdles with provider education.

New Research Assesses Factors That May Impact Adalimumab Therapy in IBD

March 8th 2019

By Kelly Davio

Article

During this week’s 14th Congress of the European Crohn’s and Colitis Organisation, multiple research teams reported on efforts to better understand the factors that impact adalimumab therapy in patients with inflammatory bowel disease (IBD).

2 New Studies Highlight Safety, Efficacy, PK of Subcutaneous CT-P13

March 7th 2019

By Kelly Davio

Article

Celltrion, maker of biosimilar infliximab CT-P13 (Remsima, Inflectra), has recently submitted an application to the European Medicines Agency for a subcutaneous formulation of the biosimilar.

Investigators Present Data on ADA Development, TDM for Biosimilar Adalimumab

March 6th 2019

By Kelly Davio

Article

The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning antidrug antibody (ADA) development related to adalimumab and therapeutic drug monitoring (TDM) of one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.

Studies Investigate Drug Survival, Discontinuation of Biologics in IBD

March 5th 2019

By Kelly Davio

Article

In patients with ulcerative colitis and Crohn disease, treatment with biologics is often effective, but adverse events or loss of response may lead to discontinuation. Several studies that will be presented at this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, sought to investigate factors related drug survival and discontinuation of biologic therapies for inflammatory bowel disease (IBD).

Researchers Present Findings on Switching to CT-P13 in IBD

March 4th 2019

By Kelly Davio

Article

This week, the European Crohn’s and Colitis Organisation (ECCO) will hold its 14th Congress in Copenhagen, Denmark. During the meeting, which runs from March 6-9, experts will gather from around the globe to discuss significant medical research into the treatment of inflammatory bowel disease (IBD), and numerous researchers will present findings on real-world switches to biosimilar infliximab CT-P13 (Inflectra, Remsima).

CT-P13 in IBD Is Safe and Effective in the Long Term, Research Shows

February 14th 2019

By Kelly Davio

Article

Evidence to support treating inflammatory bowel disease (IBD), a category that includes Crohn disease and ulcerative colitis, with biosimilar infliximab continues to develop, and several new studies highlight the safety and efficacy of long-term treatment with CT-P13 (Inflectra, Remsima).