Biological therapeutic agents, commonly known as biologics, encompass a diverse range of substances produced by cells or living organisms through various biological processes, such as controlled gene expression, antibody technologies, and recombinant DNA technologies. Over recent decades, biologics have revolutionized the management of numerous acute and chronic conditions, including hormonal deficiencies, autoimmune and inflammatory diseases, and various cancers. Today, approximately half of the pharmaceutical products available for treating malignancies are biologics. However, the development of biological drugs is often expensive and time-consuming, leading the biopharmaceutical industry to increasingly focus on developing biosimilars.

Biosimilars are biopharmaceutical products that closely resemble existing reference products in terms of safety, potency, and purity. Although they share the same amino acid sequences as their reference products, biosimilars can have unique characteristics, such as distinct 3D structures, isoform profiles, glycosylation sites, and protein aggregation. Unlike generic medicines, biosimilars are not exact copies of their reference products; however, many of their attributes—including the mechanism of action, dosage form, route of administration, therapeutic indication, and strength—must match those of the reference product.