Can biosimilar products be interchangeable? Pharmaceutical perspective in the implementation of biosimilars in oncology

Abstract

Objective To evaluate the safety in the interchangeability of biosimilar products approved for cancer treatment from a pharmaceutical perspective. Methods A literature review was carried out using the descriptors “Biosimilar”, “Oncology Therapy”, “Interchangeable drugs” and “Biological Products”, in the Sciencedirect, MEDLINE, and CAPLUS databases. Results Fifty-one articles were selected, which addressed the importance of establishing standards that prove the efficacy and safety of biosimilars with reference products, as well as the growing interest of the pharmaceutical industry in the development of biosimilars and the impact on costs and changes in the perspective of the treatment of cancer patients. Conclusions As they are large and complex molecules, it is impossible to obtain identical copies of their reference products, which generates conflicts and concerns on the part of the pharmaceutical class regarding the safety in the interchangeability of these products, highlighting the importance of pharmacovigilance in this process.

Pharmacovigilance of Biological Drugs

“…The first commercially available biosimilar appeared in the EU in 2006, while the first approval of a biosimilar in the United States (US) was in 2015 [15]. Medicinal products produced by biotechnology differ from traditional pharmaceutical chemistry methods in many aspects, including molecular size, structural complexity, stability of the final product, and the possibility of different relevant coand post-translational modifications (e.g., of the glycosylation profile).…”

“…All these peculiarities are not immediately transferable from one laboratory to another and contribute to the uniqueness of the product [4]. In particular, changes in the glycosylation pattern, a process that naturally occurs during the formation of a protein, can affect the therapeutic effect of the drug as well as lead to pharmacokinetic and pharmacodynamic modifications, altering the final product [15].…”