A study conducted by Awada S et al. stated that several factors can contribute to a lack of knowledge among community pharmacists regarding the differences between biosimilar and generic drugs. According to the authors, understanding the scientific and regulatory aspects of biosimilars can be challenging, primarily due to the limited clinical experience in dispensing biosimilars, which leads to misconceptions about their characteristics [1].
Lebanon's healthcare system is fragmented, consisting of both public and private sectors [2]. Historically, the private sector has played a dominant role, resulting in a lack of coordination and disparities in access to healthcare services This situation makes community pharmacists the first point of contact with patients to prescribe cost-effective alternatives.
The study [1] evaluated the knowledge and perception of community pharmacists regarding the use and substitution of biosimilars and generic drugs. Overall, pharmacists exhibited a good understanding of generic drugs, but their knowledge regarding the statements relating to biosimilars ranged from moderate to low.
The study revealed several misconceptions among pharmacists regarding regulatory approval and extrapolation. This occurs when a biosimilar is approved for additional indications based on data from a single approved indication. Most participants perceived generic drugs to be equally effective as the reference medication, but they considered biosimilars to be somewhat less effective. Understanding the efficacy and safety data of drugs in comparison to their reference biologicals is essential, particularly due to the differences in immunogenicity observed in biosimilars. No significant correlation was reported between the knowledge scores and the general characteristics of the pharmacists.
Despite the small sample size in the study, approximately half of the pharmacists had received training on generic drugs and biosimilars, and the majority of them expressed a need for these topics to be included in the continuing education programmes and workshops.
This result can indicate a systematic lack of knowledge and emphasizes the importance of tailored educational initiatives, training programmes, and updated guidelines to improve the understanding of biosimilars among community pharmacists. Regarding their substitution, most pharmacists agreed to substitute generic drugs if the brand was not available, while the approval of the prescriber was deemed essential for switching to biosimilar.
In Lebanon, the unified medical prescription is utilized to encourage the prescription and substitution of generic drug. Pharmacists may have the authority to perform generic drug substitutions under certain circumstances without prior approval from the doctor. This practice has become more prevalent in recent years, primarily due to medication shortages and the soaring costs of drugs, exacerbated by economic hyperinflation.
The Order of Pharmacists has initiated mandatory continuous education programmes aimed at addressing these misconceptions, fostering pharmacist‒doctor communication regarding the use and substitution of generic and biosimilar drugs, and promoting cost-effective health care. All of these efforts are undertaken with a commitment to ensuring patient safety and well-being.
The authors recommend periodically conducting a longitudinal study to ensure the representation of pharmacists in Lebanon and other similar settings.
The market uptake of biosimilars in the US and worldwide will depend on regulatory policies, for which an agreed naming and labelling system will be important. A survey of the views of European physicians on the familiarity of biosimilar medicines demonstrated the need for distinguishable non-proprietary names to be given to all biologicals [3].
Conflict of interest
The authors of the research paper [2] declared that there was no conflict of interest.
Abstracted by Georges Hatem, Researcher in the Clinical and Epidemiological Research Laboratory, Faculty of Pharmacy, Lebanese University, Hadath, Lebanon.
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Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey
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References
1. Awada S, Sayah R, Mansour M, et al. Assessment of community pharmacists’ knowledge of the differences between generic drugs and biosimilars: a pilot cross-sectional study. J Med Access. 2023;7:27550834231167049.
2. Hatem G, Goossens M. Health care system in Lebanon: a review addressing health inequalities and ethical dilemmas of frontline workers during COVID-19 pandemic. BAU Journal - Health and Wellbeing. 2022;5(1). doi.org/10.54729/YVAA4887
3. GaBI Online - Generics and Biosimilars Initiative. US pharmacists’ views on the naming and labelling of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 8]. Available from: www.gabionline.net/biosimilars/research/US-pharmacists-views-on-the-naming-and-labelling-of-biologicals
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