title: Biosimilar medical products - licensing, pharmacovigilance and interchangeability.
abstract: The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Grozdanova
authors.forename: Katerina Ancevska
authors.initials: KA
authors.lastname: Netkovska
authors.forename: Zoran
authors.initials: Z
authors.lastname: Sterjev
authors.forename: Zorica
authors.initials: Z
authors.lastname: Naumovska
authors.forename: Rubin
authors.initials: R
authors.lastname: Zarevski
authors.forename: Aleksandar
authors.initials: A
authors.lastname: Dimovski
authors.forename: Ljubica
authors.initials: L
authors.lastname: Suturkova
mesh_terms: D059451:Biosimilar Pharmaceuticals; D006801:Humans; D008004:Licensure; D060735:Pharmacovigilance; D013810:Therapeutic Equivalency
chemical_list: D059451:Biosimilar Pharmaceuticals