Gastroenterology

ICER to Assess Treatments for Ulcerative Colitis, Including Biosimilar Infliximab

September 14th 2019

By The Center for Biosimilars Staff

The Institute for Clinical and Economic Review (ICER) said this week it will review the comparative clinical effectiveness and value of therapies for ulcerative colitis, including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.

Paper Suggests That Oral Delivery of Biosimilar Infliximab, CT-P13, May Be Feasible

September 11th 2019

By Kelly Davio

Article

A paper published in Pharmaceutics describes development and validation of a production process for 5 mg tablets of infliximab, using biosimilar CT-P13 (Remsima, Inflectra), for the treatment of inflammatory bowel disease.

Patients With IBD Upset With British Columbia Switching Program

September 10th 2019

By The Center for Biosimilars Staff

Article

Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.

Ustekinumab Gets Expanded European Label With New Ulcerative Colitis Indication

September 8th 2019

By The Center for Biosimilars Staff

Article

Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis. Also approved in the European Union to treat plaque psoriasis, psoriatic arthritis, and Crohn disease, the biologic is the first available therapy that targets the interleukin-12 and -23 pathway.

British Columbia Starts Second Phase of Switching Patients to Biosimilars, This Time for IBD

September 6th 2019

By Allison Inserro

Article

This week, British Columbia began the process of transitioning patients with inflammatory bowel disease (IBD) to biosimilars.

Japanese Study: CT-P13 Is Interchangeable With Remicade in Real-World IBD Treatment

August 27th 2019

By Kelly Davio

Article

A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.

Point-of-Care Test Nearly Identical to ELISA at Detecting ADAs to Biosimilar Infliximab, SB2

August 15th 2019

By Allison Inserro

Article

A recent study of a rapid point-of-care (POC) test shows that it is virtually identical at detecting antidrug antibodies (ADAs) to a biosimilar infliximab, SB2 (Renflexis, Flixabi), as a standard enzyme-linked immunosorbent assay (ELISA) and is suitable for therapeutic drug monitoring of any infliximab product.

Paper Proposes Methodology to "Protect Health Systems" That Use Biosimilars

August 7th 2019

By Kelly Davio

Article

A study published this month proposes that biosimilars be assessed in a quantitative benefit-risk analysis to assess whether what the authors call “uncertainty in the clinical performance of biosimilars” can be countered by lower pricing.

Celltrion Begins Recruiting US Patients for Phase 3 Study of Subcutaneous CT-P13

August 1st 2019

By Kelly Davio

Article

Celltrion announced that it has begun recruiting patients with inflammatory bowel disease in Ohio for a phase 3 clinical trial of its subcutaneous formulation of biosimilar infliximab, CT-P13 (Inflectra, Remsima). The study is intended to support an application for the formulation to the FDA.

CT-P13, Reference Infliximab, and Adalimumab Demonstrate Similar Safety and Efficacy in CD

July 31st 2019

By Kelly Davio

Article

The study sought to assess the efficacy, tolerability, and safety of CT-P13 versus its reference and versus adalimumab in patients with Crohn disease (CD).