Abstract
Abstract
 Biosimilars are non-innovative copy versions of biologic medicines which are proven to be clinically equivalent to, as effective and as safe as their reference biologics. Biosimilars creates opportunities for cost savings for payers, governments, and patients compared with the reference products. Pharmacist plays an essential role in developing biosimilar medicines from manufacturing to post-marketing pharmacovigilance monitoring. The aim of the current study was to explore the level of knowledge, behaviors and practices of a sample of Iraqi pharmacists towards biosimilar medicines. The current study was a cross sectional, carried out during May 2020. A total of 264 pharmacists )143 male, 121 female) were involved in this study. A web-based self-administered questionnaire was used for data collection . Regarding pharmacists’ knowledge of biosimilar medicines, the results showed that two questions received the highest percentages of adequate answers: biosimilar medicine requires preclinical and clinical studies (58.0%) and biosimilar medicines require more comprehensive data compared to generic drugs (56.1%). In contrast, marketing authorization of biosimilar medicines is granted on the sole investigation of pharmacokinetic bioequivalence received the lowest percentage of adequate answers (21.6%). In addition, the current study showed that more experience years and male gender associated with better knowledge. With respect to perceptions of pharmacists about biosimilar medicines, two statements received the highest percentage of pharmacist agreements: biosimilar medicines are tested in terms of efficacy and safety (64.4%) and biosimilar prescription allows for reducing costs (64.4%). At the same time, 40.2% of the participating pharmacists agreed with pharmacist replacing a reference biologic medicines with its biosimilar product. In conclusion, the majority of the surveyed pharmacists had insufficient knowledge towards biosimilar medicines. The study highlighted that Iraqi pharmacists needed more accurate comprehensive information concerning biosimilar medicines.
Highlights
(6) In Iraq, a specialized committee called the ‟Biologics and Biosimilars Registration Committee (BBRC)” to register biosimilars was established by the National Regulatory Authority (NRA)
«I am in favor with the implementation of biosimilar medicines» «Biosimilar medicines are tried and tested in terms of efficacy and safety» «Biosimilar medicines are pharmacist’s concern» «I approve a pharmacist substitution of a reference biological medicine to its biosimilar product» «I approve a pharmacist substitution of a reference medicine product to its generic product» «Biosimilar medicines prescription allows for reducing healthcare costs»
More than 90% of French pharmacists answered adequately regarding the statements " A biosimilar has no meaningful differences from a reference in terms of quality" and " A biosimilar medicine has no meaningful differences from a reference in terms of efficacy " compared to (44.3%) and (51.9%) in the current study, respectively
Summary
The introduction of biologic medicines represented a significant development in therapy for many serious diseases. [1] Despite their important value, biologic medicines have become a big financial problem to the health care systems. [2] availability of “generic” copy of biological medicines would be essential as this could save billions of dollars yearly. [3] The U.S Food and Drug Administration (FDA) defines a biosimilar product as highly similar but not identical to an already licensed biologic product in terms of quality, safety, and efficacy. [4] Costs of biosimilars are about 15–30% less than the originator prices so their use creates opportunities for cost savings for payers, governments, and patients compared with the reference products since. [5]. Pharmacists are involved in educating physicians and patients about similarity, efficacy and safety of biosimilar medicines. The aim of the current study was to explore the level of knowledge, behaviors and practices of a sample of Iraqi pharmacists towards biosimilar medicines. The questionnaire investigates knowledge, behaviors and practices of pharmacists regarding biosimilar medicines. It consisted of three parts, the first part was about the sociodemographic and background characteristics of the participants. The second part addressed the knowledge of pharmacists about biosimilar medicines, this included 9 statements about quality, safety, efficacy and marketing authorization. Spearman correlation was used to measure the correlation between the pharmacist experience years and the mean of total score of correct answers to questions about biosimilar medicines. A p-value of less than 0.05 was considered to be statistically significant
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