A German study of gastroenterologist and patient acceptance of biosimilars to treat ulcerative colitis (UC) and Crohn’s disease (CD) suggests that there is reluctance among patients to accept biosimilars, and a need for better communication with physicians and education about biosimilars. The study, published in PLOS, examined gastroenterologists’ motivations for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behavior, and explored patients’ attitudes to biosimilars.
In Germany 2 infliximab biosimilars were approved in 2013 (Remsima and Inflectra) and launched in 2015. A biosimilar for etanercept was approved in Europe in January 2016, and approval of other biosimilars that will be potential treatments for inflammatory bowel disease, is very likely to occur in the coming months and years. Other biosimilars, including those for adalimumab and rituximab, are also under development. The authors note that even though Germany has some of the highest market shares in the European biosimilars market, automatic substitution of bio-originators with biosimilars by pharmacists is not allowed and there is still a marked reluctance by physicians to prescribe biosimilars. Although regulatory requirements in Europe (and the United States) ensure that approved biosimilars have the same activity and safety profile as the originator drug and the quality of the production process is guaranteed, “concerns apparently remain,” the authors write.
The PLOS study used data from a cross-sectional study undertaken in 2015-2016, that involved 25 German gastroenterologists and 136 patients, aged 18 and over, who were being treated for UC (n = 67) or CD (n = 69). Biosimilars accounted for less than 15% of all biologic therapies—88% of gastroenterologists said they preferred to prescribe a reference biological rather than a biosimilar as first-line therapy. This decreased to 72% and 80% for UC and CD, respectively, for second line treatment.
Gastroenterologists were split into 3 groups: investigative (primarily concerned with symptom improvement/disease modification, conservative (primarily concerned with safety), and other (influenced primarily by other factors). Physicians managed at least 1 patient with each disease in each of the following patient groups:
A great majority (89%) of the investigative physicians and 100% of the conservative physicians said they prescribed biosimilars instead of bio-originators to gain experience with the new products. Forty-four percent of investigative physicians believed biosimilar efficacy is equivalent to the bio-originator, and said lower cost was a consideration; 83% of conservative physicians said lower cost and “economic prescribing” played a role in selecting biosimilars.
Patients, however, showed some reluctance toward using a biosimilar. The mean percentage of patients who accepted a biosimilar without reluctance, having never been prescribed a bio-originator or biosimilar, was 60%, versus 43% of patients currently receiving a bio-originator and with no clinical reason for a change in therapy. Of those being treated with biosimilars,
A small proportion of patients would not accept treatment with a biosimilar, only the bio-originator. Physicians reported that a small proportion (mean 8% to 9%) of patients refused any form of biologic therapy, regardless of the patient’s prior experience with biologic therapy or the reason for a switch in therapy.
The study authors noted that 2 recent surveys of European gastroenterologists conducted a year apart, following greater education and use of biosimilars, found increased confidence in the use of biosimilars and a spike in the number of doctors who considered biosimilars and reference biologics as interchangeable. Cost savings remained the primary objective with using biosimilars among more than 90% of physicians, and immunogenicity was the main concern for 69% of physicians.
The authors conclude that results from their study and other surveys of European gastroenterologists suggest that patient and physician communication is very important, and further education may be needed to determine the role of other factors in influencing the conversations.
“A cautious approach is needed until sufficient long-term data are available for biosimilars to mitigate any concerns that currently exist,” the authors write, and recommend more robust product identification mechanisms to ensure traceability and accurate pharmacovigilance for biosimilar products.