ABSTRACT
PURPOSE: The purpose of the study is to analyse the degree of prescribers' knowledge about the regulation and variability in manufacturing processes (MP) in bio-drugs "innovators" (BI). METHODS: For each selected drugs, the date of authorization by the European Medicines Agency, time elapsed until the first change, total number of changes and annual rate of change (ARC) were recorded. A survey was designed with 4 parts: (a) identifying the BI prescribed; (b) knowledge of the number and ARC of each BI during its MP; (c) knowledge of comparability requirement of BI before or after the MP; (d) evaluating the utility of the information in the survey. RESULTS: Drugs selected and total number of changes: infliximab (41), adalimumab (20), abatacept (13), golimumab (7), etanercept (18), tocilizumab (6) and certolizumab. All BI had been changed in the MP after their authorisation. The survey was answered by 35 professionals from rheumatology, digestive and dermatology area. They had prescribed one or more drugs included in the survey at least once. Sixty-three percent of prescribers did not know the existence of changes relative to the MP. Thirty-seven percent of prescribers knew of their existence, but not about number or frequency. Fifty-seven percent of prescribers did not know the regulation about the comparability among BI. The rest of them knew it, but 29% related it only to biosimilar drugs. Ninety-four percent of prescribers identified information as useful. CONCLUSION: BI present a high ARC during their MP after their commercialization, without any efficacy or safety difficulties. Knowledge of this might increase confidence for biosimilars.
