Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade).
Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade).
In a Letter to the Editor of Alimentary Pharmacology & Therapeutics, researchers led by Eleni Orfanoudaki, MD, department of gastroenterology, University Hospital of Heraklion, Heraklion, Greece, reported results of a switch to the biosimilar in 15 patients who failed to respond to other biologics, including the reference infliximab. The patients were switched to the biosimilar at 5 mg/kg on weeks 0, 2, 6, and every 8 weeks thereafter.
The researchers noted that although there have been several studies on switching from the reference to the biosimilar in patients whose IBD is in remission, there have been no published results to date on the use of the biosimilar in patients with active disease and a history of loss of response to the reference.
Thus, they reported what they called “unexpected results” with the use of the biosimilar in patients with active IBD and secondary loss of response to innovator infliximab:
There were no available measurements of trough levels and anti-infliximab antibodies, however, and only limited endoscopic data for a few patients. Nonetheless, the results of the small observational study suggest that the biosimilar may be an effective alternative for IBD patients with active disease and loss of response to the reference, the researchers conclude. “The underlying mechanism of action of [the biosimilar] in these cases as well as a further validation of this finding could be assessed by future prospective controlled studies including drug pharmacokinetics," they wrote.
Reference
Orfanoudaki E, Drygiannakis I, Koutroubakis I. Letter: Is there a role for infliximab biosimilar in patients with inflammatory bowel disease with secondary loss of response to infliximab innovator? Aliment Pharmacol Ther.2018. doi:10.1111/apt.14980.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction
July 20th 2024Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Trastuzumab-dkst Shows Promising Results in Real-World Setting for HER2+ Breast Cancer
July 9th 2024A Brazilian real-world study found trastuzumab-dkst to be an effective and safe adjuvant therapy for HER2-positive (HER2+) breast cancer, with clinical outcomes comparable to reference trastuzumab.