Regulatory aspects of biological medicines in Bosnia and Herzegovina

Abstract

The use of biological medicines (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, biologics are expensive for healthcare systems in many countries, and their availability has been an issue for many patients worldwide. A biosimilar medicine (called “biosimilar“) is a medicine with a proven similarity in terms of quality, biological activity, safety, and efficacy as the approved original biological medicine (called “originator biologic“).Biosimilars generate competition in the market by lowering the prices of biologics, thereby increasing access for patients. However, there are barriers to the acceptance and use of biosimilars in respect of their safety and interchangeability with the originator biologic. In this review, we present the national regulatory framework for biologics along with its limitations, the system for monitoring the safety profile of biologics, the interchangeability guideline, and a list of approved and available biologics in Bosnia and Herzegovina. Recommendations were also made here in order to create opportunities for better acceptance of biosimilars and thus 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 of biosimilars and biologics among healthcare providers should be raised through continuous education and workshops, and by including this important topic in graduate and post-graduate curricula in the country.