Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.
The cost of cancer care is on the rise worldwide, and biosimilars present one option for bringing down costs. However, those savings depend on adoption and use of biosimilars, and hesitancy to use these agents on the part of prescribers has been well documented in the literature. In a study newly published in ESMO Open, investigators reported on a survey conducted among European Society for Medical Oncology (ESMO) members and attendees of the 2017 ESMO Congress in Madrid, Spain, concerning biosimilars.
The 19-question survey, which included checkbox answers and open-ended questions, was administered between September 2017 and October 2017. A total of 393 responses were received from prescribers from Europe (n = 255) and the Asia—Pacific region (n = 80).
When asked to rate their knowledge of biosimilars on a scale on which 1 represented very low knowledge and 5 represented very high knowledge, the most commonly selected option was 3 (45.5%). Most (74.6%) prescribers were able to identify the appropriate definition of a biosimilar. With respect to their comfort using EMA-approved biosimilars, most prescribers (57.4%) ranked their level of comfort at either a 4 or 5.
However, only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia—Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.
Most prescribers (61.1%) ranked their knowledge of the biosimilar development process as either a 3 or a 4. Safety and efficacy data were best understood, followed by immunogenicity data. A total of 45.2% of respondents selected the most appropriate definition of “sensitive indication” in the biosimilar development process, and when asked about how much knowledge they have regarding clinical trial design, 59.8% ranked their knowledge at 3 or 4. However, 27.9% said that a comparative study should be conducted in all indications of the reference, which suggests that there is a lack of awareness of the extrapolation of indications.
Overall, 86.7% of prescribers called on ESMO to provide more biosimilars education activities. Among the activities suggested by respondents, clinical trial design, clinical trial end points, bioequivalence criteria and studies, approval procedures, pricing and reimbursement, and treatment outcome comparisons between reference products and biosimilars were all raised as fruitful areas for education.
In a statement, the paper’s first author, Rosa Giuliani, MD, a medical oncologist at The Christie Hospital in Manchester, United Kingdom, and chair of the ESMO Global Policy Committee, said that a particular point of interest about providers’ requests concerning education is the fact that respondents from the European region were most interested in gaining further education about clinical safety and efficacy. However, those from the Asia—Pacific region were eager for more discussion about how to use biosimilars in low-resource nations.
Giuliani also said that she was surprised by the low use of biosimilars reported in the survey, but added, “I want to be optimistic, and maybe one explanation could be that when answering the question, responders were possibly focusing more on of the new wave of biosimilars. These are the biosimilars for monoclonal antibodies and are still not available in many countries, so that’s why they’re not used.” Additionally, she added, “uptake of the first wave of biosimilars in oncology has been extremely low and heterogeneous in different countries, and I believe this may be partly explained by the lack of clear and extensive communication about the science behind biosimilars. Therefore, it is now imperative to ensure that the oncology community learns the scientific and regulatory pathways that lead to approval of biosimilars in the [European Union].”
Giuliani R, Tabernero J, Cardoso F, McGregor KH, Vyas M, de Vries EGE. Knowledge and use of biosimilars in oncology: a survey by the European Society for Medical Oncology. ESMO Open. 2019;4:e000460. doi: 10.1136/esmoopen-2018-000460.