IDEAS home Printed from https://ideas.repec.org/a/gam/jijerp/v17y2020i16p5800-d397268.html
   My bibliography  Save this article

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Author

Listed:
  • 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)

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.

Suggested Citation

  • Vesa Halimi & Armond Daci & Katerina Ancevska Netkovska & Ljubica Suturkova & Zaheer-Ud-Din Babar & Aleksandra Grozdanova, 2020. "Clinical and Regulatory Concerns of Biosimilars: A Review of Literature," IJERPH, MDPI, vol. 17(16), pages 1-17, August.
  • Handle: RePEc:gam:jijerp:v:17:y:2020:i:16:p:5800-:d:397268
    as

    Download full text from publisher

    File URL: https://www.mdpi.com/1660-4601/17/16/5800/pdf
    Download Restriction: no

    File URL: https://www.mdpi.com/1660-4601/17/16/5800/
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    1. Valeria Belleudi & Francesco Trotta & Antonio Addis & Ylenia Ingrasciotta & Valentina Ientile & Michele Tari & Rosa Gini & Maurizio Pastorello & Salvatore Scondotto & Pasquale Cananzi & Giuseppe Trave, 2019. "Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study," Drug Safety, Springer, vol. 42(12), pages 1437-1447, December.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.

      Corrections

      All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:gam:jijerp:v:17:y:2020:i:16:p:5800-:d:397268. See general information about how to correct material in RePEc.

      If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

      If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

      If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

      For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: MDPI Indexing Manager (email available below). General contact details of provider: https://www.mdpi.com .

      Please note that corrections may take a couple of weeks to filter through the various RePEc services.

      IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.