Regulatory aspects of biological medicines in Bosnia and Herzegovina

Authors

  • Biljana Tubić Department of Pharmacy, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina; Agency for Medicines and Medical Devices of Bosnia and Herzegovina, Banja Luka, Bosnia and Herzegovina https://orcid.org/0000-0002-0527-6327
  • Saša Jungić Department of Medical Oncology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina; Clinic of Medical Oncology, University Clinical Centre Republic of Srpska, Banja Luka, Bosnia and Herzegovina

DOI:

https://doi.org/10.17305/bjbms.2021.6910

Keywords:

Original biological medicines (originator biologics), biosimilars, regulatory approach, interchangeability, safety

Abstract

The use of the biological medicines, also called “biologics,” has contributed to the progress of the treatment of many chronic diseases, such as cancer, rheumatoid arthritis, Crohn’s disease, multiple sclerosis, and psoriasis. However, biologicals are expensive for healthcare systems in several countries. Their availability has been a global issue, which has affected many patients that suffer from various diseases. A biosimilar medicine, also called “biosimilar,” is a medicine with similar characteristics in terms of quality, biological activity, safety, and efficacy as the approved original biological medicine, known as “originator biologic.” Biosimilars generate competition within the market because they lower the prices of biologics and thus allow for an increase in patient access. However, there are barriers when it comes to the acceptability rate of biosimilars and how interchangeable they are with the originator biologic. In this review, we present a national regulatory framework for biologics along with its limitations, a system of monitoring the safety profile of biologics, the guideline for interchangeability, and a list of approved and available biologics in Bosnia and Herzegovina. Additionally, recommendations were made here in order to provide opportunities for greater acceptance of biosimilars and better access to biologics. These recommendations include, but are not limited to, strengthening the national regulatory framework for biologics, capacity building, increasing awareness among healthcare providers for reporting adverse drug events and active pharmacovigilance, and better definitions of interchangeability. Finally, awareness among healthcare providers regarding biosimilars and biologics should be raised through continuous education and workshops, and by including this important topic in the graduate and postgraduate curriculum programs in the country.

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Regulatory aspects of biological medicines in Bosnia and Herzegovina

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Published

2022-03-23

How to Cite

1.
Tubić B, Jungić S. Regulatory aspects of biological medicines in Bosnia and Herzegovina. Bosn J of Basic Med Sci [Internet]. 2022Mar.23 [cited 2022Jul.4];. Available from: https://bjbms.org/ojs/index.php/bjbms/article/view/6910

Issue

Section

Reviews