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.