"Biosimilar" generic version of biologic products?

Biosimilars are currently popular after the expiry date of patents for biological reference products have expired or soon will expire. Besides, this ‘copycat’ version biologic offers much lower costs as compared to products, thus promoting better patient access treatment certain diseases such cancer, inflammatory diseases, skin disorders, and diabetes. This review aims determine differences between biosimilars generic drugs highlight some issues related biosimilar comparability, interchangeability, immunogenicity, extrapolation indication, current legislation, pharmacovigilance, naming system. Scientific sources from PubMed, Google Scholar, ScienceDirect, Elsevier were accessed preparation article. not they a larger complex structure drugs. Due that, highly similar but identical products. Many regulatory authorities authorized under distinct process that subjected them comprehensive comparability studies with their (analytical, nonclinical in vitro, vivo studies, clinical trials). Additional evidence interchangeability indication immunogenicity profile assessments, pharmacovigilance also beneficial assess efficacy, safety, quality before and/or receiving approval. different due complexity manufacturing process. More required ensure benefits outweigh risks.