Gastroenterology

The Top Biosimilars News for the Week of July 2, 2018

July 6th 2018

By The Center for Biosimilars Staff

Article

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

Study Examines Potential Role of Biologics in Treating Primary Sclerosing Cholangitis

June 30th 2018

By The Center for Biosimilars Staff

Article

Primary sclerosing cholangitis (PSC) is a chronic, immune-mediated, progressive biliary disease that is closely associated with inflammatory bowel disease (IBD). PSC has no cure, and up to 40% of cases eventually require patients to receive liver transplants. Given the efficacy of biologics in treating IBD, the potential to treat PSC with these same drugs is a matter of interest for healthcare providers.

Review Addresses the Role of Anti-TNFs in Intestinal Behçet Disease

June 28th 2018

By The Center for Biosimilars Staff

Article

Intestinal Behçet disease (BD), which is an immune-mediated, chronic, inflammatory intestinal disease, can be difficult to treat, in part because the pathogenesis of intestinal BD is unclear. However, as data for using anti–tumor necrosis factor (anti-TNF) drugs have been accumulating in the treatment of inflammatory bowel disease (IBD), which has a similar clinical presentation, the potential to treat BD with these agents is under investigation.

Switching Between Reference Infliximab and CT-P13 Is Unlikely to Evoke Different ADAs

June 19th 2018

By Kelly Davio

Article

A new study, published in Alimentary Pharmacology and Therapeutics, sought to test antigenic comparability between the reference infliximab and the biosimilar.

Spanish Study: Switching to Biosimilar Infliximab in IBD Is Safe, Effective at 12 Months

June 18th 2018

By Kelly Davio

Article

Researchers from Spain, where biosimilar use is encouraged as a way to save on costs and expand access to biologic therapies, recently reported on a multicenter prospective observational study in patients with inflammatory bowel disease (IBD) who switched from reference infliximab to a biosimilar, CT-P13 (Inflectra, Remsima).

Gastroenterologist Recounts Clinical Experience With Switching Patients to Biosimilars

June 11th 2018

By Kelly Davio

Article

“I see no reason as a healthcare provider to intentionally go back and forth needlessly, but I see no concerns that, if I do that, bad things would happen,” said Jason Schairer, MD.

Effective Infliximab Treatment for CD Is Associated With Improved Mental Health

June 11th 2018

By Kelly Davio

Article

Crohn disease (CD) can involve physical, psychological, and social impairments that negatively impact patients’ quality of life, and high levels of anxiety and depression have been observed in patients with CD.

Review Finds That Switching to Biosimilar Infliximab in Patients with IBD is Acceptable

June 7th 2018

By Kelly Davio

Article

The question of whether to switch patients from a reference biologic to an available biosimilar has been the subject of extensive debate, especially in patients with inflammatory bowel disease (IBD), an indication in which evidence on relevant clinical outcomes after switching is limited.

Celltrion Reports Positive Phase 1 Results for Subcutaneous Inflectra in CD

June 5th 2018

By Kelly Davio

Article

Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).

FDA Approves JAK Inhibitor to Treat Ulcerative Colitis, Providing an Alternative to Anti-TNF Agents

June 2nd 2018

By Samantha DiGrande

Article

This week, the FDA approved an expanded indication of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz) to include adults with moderate to severe ulcerative colitis. Tofacitinib is the first oral medicine approved for long-term use in UC, and provides an alternative to anti–tumor necrosis factor (anti-TNF) drugs that must be injected or infused.