Physicians' Views (Particular and Collective)
Danese et al. performed a very informative web survey on ECCO members' knowledge on biosimilar monoclonal antibodies. Although being a relatively new topic, the key concepts of biosimilar and the principal theoretical advantage (the price) were well recognized by a substantial portion (70% to 80%) of the participants. However, only 24% considered 'extrapolation' to all indications correct, and a surprising 61% 'felt little or no confidence in using biosimilars in their everyday clinical practice'. These types of concern were found to be also very common in a recent survey of Canadian rheumatologists. Perhaps even more interesting is reviewing the statements of scientific societies in recently available 'position statements'. In all cases, we observe emphasis on the differences between 'generics' and 'biosimilars', but they differ somewhat in the statements. We see often sentences asking for 'meet appropriate quality standards' or 'The approval of a biosimilar must follow the preclinical and clinical tests stated in European law'. This phrasing clearly suggests a not very high degree of confidence, perhaps explaining part of the 61% level of nonconfidence shown in the Danese poll. Position statements do not always agree with regulatory authorities and in fact none of them accepts 'extrapolation', and some controversy between EMA and ECCO followed ECCO's position paper.