A recent study presented at EULAR found that a substantial number of patients who switched treatment from reference etanercept to a biosimilar switched back to the reference after a short period.
A recent study, sponsored by Pfizer and presented in a European League Against Rheumatism (EULAR) poster session earlier this month, found that a substantial number of patients who had switched treatment from reference etanercept to a biosimilar treatment switched back to the reference product after a short time.
The study’s authors sought to describe the position of the reference etanercept treatment within the Swedish biologics market for rheumatic diseases, including rheumatoid arthritis, before and after the launch of a biosimilar product.
The market share for each product was tracked using prescription data from the Swedish Prescription Registry (which covers 100% of prescriptions written in Sweden) for each month during the period between November 2015 and October 2016. The researchers tracked the switching dynamics of patients initiating the biosimilar treatment between April 2016 and October 2016, and measured the proportion of patients naïve to biologic treatment as well as the proportion of patients who had been treated with etanercept, adalimumab, and other biologic agents in the 12 months prior to initiating treatment with biosimilar etanercept.
The researchers found that, in the first 6 months after biosimilar etanercept was launched in the Swedish market, the market share of reference etanercept decreased from 40% to 31%. A total of 2439 patients were found to have initiated treatment with biosimilar etanercept, and of this group, 40.1% were naïve to biologic treatments, 48.3% had previously been treated with reference etanercept, 4.4% had been previously treated with adalimumab, and 7.2% had been previously treated with other biologics.
Among the group of patients who initiated biosimilar etanercept after having previously received its reference, 7% switched back to the reference after an average period of 43 days. Of the group who had previously received adalimumab, 6% switched back to treatment with adalimumab after an average of 57 days.
The researchers concluded that a switch from reference products to cheaper biosimilars is very likely to be a result of economic factors, however, the reasons for patients’ switching back to reference products is not clear. The researchers posit patient preference and clinical factors as possible reasons for such a return, but they state that longer-term studies will be necessary in order to confirm these preliminary findings.
The results of this study echo those of a previous study, also funded by Pfizer and conducted in Germany by the same research group, which found that 10% of patients who switched to biosimilar etanercept returned to treatment with its reference within 3 months. In the German study, 72% of patients who switched back to reference products returned to the same administration method they had used previously, suggesting that device type may have played a role.
As health systems contend with high prescription drug costs and patients find themselves with questions and concerns about switching, other European nations are turning to education programs to help keep patients on lower-cost biosimilars, though it remains to be seen whether such programs can prevent patients from switching back to reference products in the longer term.
Unlocking Biosimilar Potential in Specialty Pharmacies With Legislative Support, Formulary Changes
April 24th 2025Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
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.
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.
Biosimilar and Biologic Use Increasing in Greek Patients With IBD
April 19th 2025A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.