Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Vesa Halimi, Armond Daci, Katerina Ancevska Netkovska, Ljubica Suturkova, Zaheer-Ud-Din Babar and Aleksandra Grozdanova
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Vesa Halimi: Faculty of Pharmacy, University Ss. Cyril and Methodius, 1000 Skopje, North Macedonia
Armond Daci: Department of Pharmacy, Faculty of Medicine, University of Prishtina, 10000 Prishtina, Kosovo
Katerina Ancevska Netkovska: Faculty of Pharmacy, University Ss. Cyril and Methodius, 1000 Skopje, North Macedonia
Ljubica Suturkova: Faculty of Pharmacy, University Ss. Cyril and Methodius, 1000 Skopje, North Macedonia
Zaheer-Ud-Din Babar: Department of Pharmacy, University of Huddersfield, Huddersfield, West Yorkshire HD1 3DH, UK
Aleksandra Grozdanova: Faculty of Pharmacy, University Ss. Cyril and Methodius, 1000 Skopje, North Macedonia

IJERPH, 2020, vol. 17, issue 16, 1-17

Abstract: Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP’s key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.

Keywords: biosimilars; clinical practice; interchangeability; extrapolation; pharmacovigilance; regulatory; knowledge; confidence; education (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2020
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