A recent study aimed to evaluate patients’ and nurses’ preferences for the autoinjector for a biosimilar adalimumab marketed as Imraldi in the European Union versus autoinjectors of reference adalimumab or reference etanercept.
Medication nonadherence is common in patients receiving biologic anti—tumor necrosis factor (anti-TNF) treatment and is associated with increased disease activity and disease flares, loss of responsiveness to anti-TNF treatment, poorer quality of life, increased healthcare expenditures, and higher disability in patients. Patients with inflammatory conditions and nurses tend to prefer autoinjectors over prefilled syringes, studies have shown, as autoinjectors may be easier to use, more convenient, and less painful than syringes, which can increase adherence.
A recent study aimed to evaluate patients’ and nurses’ preferences for the autoinjector for the biosimilar adalimumab marketed as Imraldi in the European Union versus autoinjectors of reference adalimumab (Humira) or reference etanercept (Enbrel). The authors said head-to-head comparative studies of the biosimilar's autoinjector versus other autoinjectors of biologic anti-TNF therapies are needed to determine whether the biosimilar's autoinjector attributes improve patient and nurse satisfaction. Improving satisfaction could improve adherence as well, which could increase treatment efficacy and reduce costs.
The biosimilar's device features a nonslip surface and a rounded 4-sided shape, clicks audibly to indicate the start and end of dose administration, has a button-free initiation mechanism, has small needle size, and has a large medication-viewing window with an indicator to confirm that the injection is complete.
There were 2 face-to-face surveys of patients as well as nurses experienced with educating patients. The first study compared the autoinjectors of biosimilar and reference adalimumab, and the second compared the autoinjectors of biosimilar adalimumab and reference etanercept.
Only nurses with sufficient experience administering autoinjector devices and training patients how to use them were eligible to take part. Patients were aged 18 to 65 years and had a diagnosis of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, or Crohn disease. They were required to have been injecting the reference adalimumab themselves via an autoinjector for at  least 3 months; prior experience with the biosimilar or etanercept autoinjectors was not required for enrollment.
Overall, 101 nurses (United Kingdom, n = 50; Germany, n = 51) and 151 patients (United Kingdom, n = 90; Germany, n = 61) participated in the studies.
In the first study, 85% of nurses and 78% of patients preferred the biosimilar's autoinjector over the reference adalimumab autoinjector (P  < .001). In the second study, 86% of nurses and 79% of patients preferred the biosimilar's autoinjector over the etanercept autoinjector (P  < .001). Survey respondents preferred the biosimilar's autoinjector for its ergonomics, ease of use, ease of grip, and button-free initiation mechanism.
Most nurses indicated they would recommend the biosimilar's autoinjector over the reference adalimumab or etanercept autoinjectors, and most patients indicated they would choose the biosimilar's autoinjector over either reference autoinjector to continue treatment. For patients, results were consistent irrespective of age, country, or condition; for nurses, results were consistent regardless of country, specialty, or prior familiarity with the etanercept autoinjector.
There were 2 main limitations to the survey:
The study was funded by Biogen, part of Samsung Bioepis, maker of Imraldi, and 2 of the 3 authors are employed by the company.
Reference
Fenwick S, Thakur K, Munro D. Nurse and patient perceptions and preferences for subcutaneous autoinjectors for inflammatory joint or bowel disease: findings from a European survey. [published online February 21, 2019]. Rheumatol Ther. doi: 10.1007/s40744-019-0144-8.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Sintilimab, Bevacizumab Biosimilar, HAIC Improves Survival in Patients With Unresectable HCC
April 14th 2024Positive results of sintilimab, IBI305, and hepatic arterial infusion chemotherapy (HAIC) treatment showed shrinking tumors and previously converting inoperable hepatocellular carcinoma (HCC) to resectable HCC with manageable adverse effects.