- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Etanercept Reverse Switching Is Measured in Netherlands Study
Investigators in the Netherlands observed that 13.7% of patients with rheumatic disease had switched back to etanercept originator at 4.4 years from baseline.
Clinicians should expect 1 out of 7 patients with rheumatic disease to reverse switch from biosimilar etanercept (BS-ETA) to the originator brand (OR-ETA), investigators concluded in a Netherlands study presented at EULAR 2021.
Authors of the study sought to evaluate the incidence of reverse switching among patients (N = 342) who were switched to BS-ETA from OR-ETA. They noted the findings are relevant because reverse switching reduces the savings achieved by switching patients to BS-ETA.
Prior, open label studies reported that from 2.7% to 7.4% of patients retransitioned to originator etanercept after switching to the biosimilar, the authors noted.
In their study, 9.4% of patients reverse switched to the originator by the 1-year mark following initiation on BS-ETA, whereas 69.7% persisted on the biosimilar agent. By the end of the follow-up period, 4.4 years from baseline, 47 patients or 13.7% had retransitioned to OR-ETA. The median time before reverse switching was slightly less than 6 months.
Expressed in odds ratios (OR), where a value greater than 1 indicates higher odds of an association, the univariate determinants for reverse switching were identified as initiating corticosteroids or intensifying immunomodulatory treatments (OR 2.37; 95% CI, 1.03-5.45) and the number of rheumatology department visits (OR 2.0; 95% C, 1.55-2.74).
In multivariate analysis, only rheumatology department visits remained significantly associated with reverse switching (OR 2.19; 95% CI, 1.60-3.01).
Investigators concluded not only that roughly 14% of patients would switch back to OR-ETA but also patients who visit the rheumatology department more often were at higher risk for retransitioning.
They did not identify the brand or brands of etanercept biosimilar included in the study. The originator is Enbrel, an Amgen product.
Reference
Meijboom RW, Gardarsdottir H, Becker ML, ten Wolde S, Egberts ACG, Giezen TJ. Incidence and determinants associated with retransitioning from etanercept biosimilar to etanercept originator. Presented at EULAR 2021: June 2-5, 2021. Poster 0637.
Comparable Disease Activity, Drug Persistence in Patients With JIA Who Switch to Biosimilars
September 12th 2024Switching children with juvenile idiopathic arthritis (JIA) from anti-tumor necrosis factor (TNF) originators to biosimilars showed similar disease activity and drug persistence, with good tolerability, supporting the safety and effectiveness of non-medical switching.
BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
September 9th 2024Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
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.
The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings
September 4th 2024A recent study highlights that although biosimilars have led to significant price reductions, originator products with sole preferred coverage strategies have maintained market share, suggesting that increased biosimilar uptake alone may not fully leverage the market's competitive and cost-saving potential.
