Biosimilars vs. Biologics: Clinical Efficacy and Safety

Ms.Khushboo Gupta
Faculty of Pharmacy, Kalinga University, Naya Raipur (C.G) India
khushboo.gupta@kalingauniversity.ac.in

Biosimilars are biologic medications that bear only slight variations in therapeutically inert ingredients but otherwise closely resemble reference biologics that have already received approval in terms of quality, safety, and efficacy. Biosimilars are sophisticated, large-molecule medications created through biological processes; unlike generics, which are precise chemical replicas of small-molecule medications, they are marginally different from but functionally equal to their reference products. Clinical research has demonstrated that when it comes to therapeutic outcomes for the treatment of diseases like diabetes, autoimmune disorders, and cancer, biosimilars and biologics are comparable. Before approving a biosimilar, regulatory agencies such as the FDA and EMA conduct a thorough assessment of the biosimilar’s safety, effectiveness, and immunogenicity. Post-marketing surveillance keeps an eye on their long-term efficacy and safety. Real-world data is increasingly supporting the use of biosimilars as safe, affordable substitutes for biologics, providing greater access to pricey medicines without sacrificing clinical outcomes, despite worries about minor structural variations.

Citations –
World Health Organization (WHO) – Biosimilars
Provides guidance on the safety, efficacy, and regulatory frameworks for biosimilars.
WHO Biosimilar Guidelines
U.S. Food and Drug Administration (FDA) – Biosimilar Development, Review, and Approval