Practice

Study Finds that CT-P13 May Be Effective in Takayasu Arteritis

January 17th 2019

By Samantha DiGrande

Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.

Rituximab Biosimilar Is Safe, Effective, and Cost-Saving in RA, but When Will US Patients Benefit?

January 17th 2019

By Kelly Davio

Article

When Celltrion and Teva’s biosimilar rituximab, CT-P10, earned FDA approval under the brand name Truxima in late 2018, it was authorized only for oncology indications, as the drug’s sponsors did not seek indications in inflammatory diseases because of issues related to patent exclusivity on some indications. However, the biosimilar has shown efficacy in treating rheumatoid arthritis (RA), and a European analysis found that the budget impact of introducing CT-P10 could dramatically reduce the cost to treat severe RA.

New Research Investigates Shelf Life, Device Usability of Biosimilar Adalimumab

January 16th 2019

By Kelly Davio

Article

Samsung Bioepis’ biosimilar adalimumab, SB5, has been approved in the European Union under the name Imraldi on the basis of clinical studies including a phase 3 study in patients with rheumatoid arthritis. Now that the biosimilar has begun to make its way to EU patients, investigators are publishing new data on other key facets of the product, including its shelf life and device usability.

New Research Finds Switching to CT-P13 Is Safe in IBD, and So Is Switching to the Reference

January 14th 2019

By Kelly Davio

Article

The body of evidence demonstrating the safety and efficacy of biosimilar infliximab, CT-P13 (Inflectra, Remsima), is growing, particularly in the extrapolated indication of inflammatory bowel disease (IBD). This month saw the publication of 2 new studies that provided reassuring data on CT-P13, one of which focused on switching pediatric patients with IBD to CT-P13, and the second of which explored switching to the reference infliximab from the biosimilar in adults with IBD.

MAPLE Study Supports Clinical Equivalence of ABP 215 and Reference Bevacizumab

January 11th 2019

By Kelly Davio

Article

This week, investigators published the results of the MAPLE study, a phase 3 trial of Amgen’s bevacizumab in comparison with the reference, Avastin, in patients with advance nonsquamous non–small cell lung cancer who were also receiving first-line chemotherapy with carboplatin and paclitaxel.

UK Patients Report Negative Experiences With Switches to Biosimilars

January 9th 2019

By Kelly Davio

Article

While 63% of respondents who had switched to a biosimilar said that they had been consulted in some form prior to the transition, 37% said that they had not been consulted (despite the fact that National Health Service guidelines require the patient to be consulted about such a switch).

Community Oncology Alliance Forms Biosimilars Committee Aimed at Educating Providers

January 7th 2019

By Samantha DiGrande

Article

The Community Oncology Alliance (COA) recently formed a standing Biosimilars Committee for which The Center for Biosimilars® advisory board member, Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina, was named chair alongside co-chairs immediate past president of COA, Jeff Vacirca MD, FACP, and Michael Diaz, MD, incoming COA president.

Lack of Biosimilar Awareness Persists in the US and Europe, Review Finds

January 2nd 2019

By Kelly Davio

Article

Biosimilars have the potential to deliver substantial savings to the healthcare system, but only insofar as they are adopted and used in clinical practice. A newly published systematic review evaluated US and European healthcare provider knowledge, perceptions, and prescribing behaviors related to biosimilars, and it found that providers are still taking a cautious approach to biosimilars in part because of a lack of awareness of these medicines.

Rituximab May Treat Early-Onset Nephrotic Syndrome

January 1st 2019

By Kelly Davio

Article

In children, idiopathic nephrotic syndrome (NS) generally responds well to treatment with corticosteroids, but long-term use of steroids in children can produce adverse effects (AEs) such as growth impairment and hypertension. Calcineurin inhibitors, too, are associated with AEs, including toxicity and diabetes. Rituximab has been proposed as an option for difficult-to-treat childhood-onset NS, and a recent study evaluated the efficacy and safety of a single dose of rituximab in this setting.

Risk of TB High in Indian Patients With IBD Who Receive Infliximab

December 31st 2018

By Samantha DiGrande

Article

Data on the risk of tuberculosis (TB) reactivation with infliximab therapy in patients with inflammatory bowel disease (IBD) who are from countries where TB is particularly prevalent, such as India, remains limited. A recent study sought to evaluate the rate of tubercular reactivation with infliximab in a cohort of patients with IBD.