A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.
The year 2019 brought new evidence supporting nonmedical switching from infliximab (Remicade) and etanercept (Enbrel) to biosimilars (CT-P13 and SB4, respectively) for inflammatory arthritis, plus research suggesting using positive messages with patients improves willingness to switch to biosimilars.
In a year-in-review article published in Nature Reviews Rheumatology, author Jonathan Kay of UMass Memorial Medical Center and the University of Massachusetts Medical School outlines studies published in last year on nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.1
Infliximab biosimilar CT-P13
In 2019, results were published from the 26-week open-label extension of the NOR-SWITCH trial,2 which had previously established similar efficacy and safety upon nonmedical switching from infliximab to biosimilar CT-P13 in 2017. In the extension of the trial, patients from the infliximab group were switched to CT-P13, and patients who had switched to CT-P13 remained on the biosimilar. Similar proportions of patients in the 2 groups experienced disease activity worsening. Rates of adverse events, infusion reactions, and antidrug antibodies were also similar, providing additional evidence supporting nonmedical switching from infliximab to its biosimilar CT-P13.
Real-world evidence for etanercept biosimilar SB4
In 2016, Denmark mandated etanercept be replaced with its lower-cost biosimilar SB4 in most patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. An observational cohort study published in 2019 revealed the real-world effects of this mandatory switch.3 There were no differences in disease activity comparing the 3 months before and after the switch, a smaller proportion of switched patients withdrew from treatment compared to those who remained on etanercept, and 1-year adjusted retention rates were similar. Reasons for switching back to etanercept were mainly subjective, and according to Kay, some switches back to the originator were likely due to the nocebo effect.
Communicating with patients about biosimilars
Also published in 2019 was a randomized controlled trial in New Zealand in which patients being treated with originator biologics received 1 of 4 video explanations on biosimilars, 2 with positive messaging and 2 negative. Those participants who saw a positively framed message were more than twice as willing to switch to a biosimilar and thought the biosimilar would be more effective compared to those who saw negative messages.4
Kay also notes the previously published BIO-SPAN study, in which staff were instructed to inform patients of cost savings and lower rate of injection site reactions associated with SB4; they were also trained to discuss the nocebo effect with patients. In that study, 99% of patients who were asked to switch to SB4 were willing to switch.5
According to the author, because the messages patients receive from healthcare providers shape their expectations, emphasizing the potential benefits of biosimilars may increase willingness to switch, reduce failure due to the nocebo effect, and improve medication persistence.
References:
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
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.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.