Hospital specialists and pharmacists surveyed about biosimilars Posted 08/12/2017

Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European countries [1, 2]. In contrast with the procedures for their approval [3], position papers from scientific societies suggest that biosimilars need to be tested in well-designed, randomized, controlled clinical trials, especially for extrapolation of indications [4, 5]. Nevertheless, switches with originators are becoming common and no serious adverse effects have been reported to date [6-8].

Knowledge of hospital specialists’ opinions is important to target interventions to boost their use. Therefore, author Luca Pasina and colleagues from the Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy carried out a survey of hospital specialists [9]. The aims of the survey were to evaluate: (i) the hospital specialist’s attitude to prescribing biosimilars; and (ii) the hospital specialist’s opinion about the quality, efficacy and safety of biosimilars.

The survey was conducted between 1 April and 30 September 2015 in the 15 Local Health Units of the Lombardy Region in Italy. Four independent researchers discussed the scientific principles that allow the licensing of biosimilars and the potential economic benefits of infliximab, somatropin, human erythropoietin and filgrastim. Four specialists in rheumatology, gastroenterology, nephrology and paediatricians then reported their opinions and experience. Hospital pharmacists’ opinions were also collected.

A total of 214 specialists and 36 hospital pharmacists completed the survey.  A summary of the main results is available upon request.  Biosimilars were recognized as an important opportunity for savings by 152 (71.0%) specialists and 19 (52.7%) hospital pharmacists. However, knowledge of the scientific principles for licensing biosimilars was considered poor by most of the specialists (about 74%). In line with expert opinions, about 51% of the specialists reported that they prescribed biosimilars only to naïve patients.

An important difference between specialists and hospital pharmacists was related to the drug indications approved on the basis of extrapolation of indications: 41% of specialists in comparison with 8% of hospital pharmacists had doubts about the scientific validity of this principle. Prejudices related to the supposed lower efficacy of biosimilars (especially in the indications obtained by extrapolation) and concern for the higher risk of adverse drug reactions (especially immunogenic) were the main reasons for specialists to doubt biosimilars. However, no risk has emerged in clinical trials or from the European EudraVigilance database [8, 10, 11].

Finally, the opinions of the specialists were analysed which is available upon request. Interestingly, specialists’ opinions differed in relation to their experience with biosimilars: nephrologists and paediatricians more frequently reported favourable opinions.

The authors concluded that ‘educational interventions will be urgently required with the forthcoming approval of biosimilars under active development to avoid the risk of patients continuing to use more expensive drugs’.

This study was supported by grants from the Region Health Directorate of the Lombardy Region.

Conflict of interest
The authors of the research paper [9] declared that there was no conflict of interest.

Abstracted by Luca Pasina, Head of the Pharmacotherapy and Appropriateness of Drug Prescription Unit, IRCCS – Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.

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