US biotech major Biogen (Nasdaq: BIIB) is presenting real-world data studies demonstrating the safety and efficacy Benepali, the company’s biosimilar version of Enbrel (etanercept).
Biogen also aims to show high levels of acceptance and adherence in patients being treated with the drug, and to discuss ways of bolstering adoption by avoiding the ‘nocebo effect’, at the ongoing Annual European Congress of Rheumatology (EULAR).
Data from studies involving 1,548 patients with rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis, show that disease activity was “largely unaffected” at three months post-switch and comparable to that observed in the three months prior to switch.
Further real-world data highlight patients’ acceptance of switching, and adherence to the new treatment. In one UK study of 96 adult patients, 99% agreed to switch and 91% remained on Benepali at six months.
Alpna Seth, head of biosimilars at Biogen, said: “I think this kind of real-world evidence is valuable. It increases the level of confidence, for skeptics out there, to see the data and know that these products are high quality, that there's a high level of acceptance.”
“These data further increase the confidence of the healthcare system to switch to Benepali.”
One issue Biogen is attempting to address is the problem of patients’ negative expectations of biosimilar treatments, which can affect outcomes.
Dr Seth also said: “Different countries in Europe are in different stages of adoption, so it's important to share best practices.”
“For example, one set of data at a EULAR symposium will talk about the nocebo effect, which can be a problem with biosimilars.”
“There are lots of learnings from doctors and hospitals who have recognized this as a potential issue and have been able to provide guidance to patients and to educate them about biosimilars, about the fact that they are efficacious and just as safe as the bio-original, and that can have a tremendous impact.”
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