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.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain
April 24th 2025Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.