Overview of Biosimilars

Biotechnological drugs are increasingly crucial in modern medicine, which anticipated to occupy half the pharmaceutical market soon. Patent expirations have spurred the emergence of biosimilars, akin to follow on biologics aiming to replicate original biotech medicines. While a couple of biosimilars gained approval in the EU, others are in the pipeline. Despite their potential to reduce treatment costs, our understanding and long-term safety data for biosimilars, including immunogenicity, remain limited. Comparing biosimilars to classic chemical drug generics is vital, demanding focused discussions among physicians. Regulatory clarity, safety concerns, pharmacovigilance, automatic substitution policies, nomenclature, and labeling rules constitute crucial areas requiring attention as biosimilars evolve in the healthcare landscape.