What is a biosimilar?
A biosimilar is a biological product that is highly similar to an existing, approved reference biologic, with no clinically meaningful differences in terms of safety, purity, or potency. Unlike generics, which are chemically identical to their small-molecule counterparts, biosimilars are derived from living organisms and may exhibit minor differences in clinically inactive components due to natural variability in the manufacturing process. These products undergo rigorous comparative testing to demonstrate similarity in structure, function, pharmacokinetics, and clinical outcomes.
Why are biosimilars important in healthcare?
Biosimilars increase treatment access by providing more affordable alternatives to high-cost biologics, often in areas such as oncology, immunology, and endocrinology. They support healthcare system sustainability by reducing expenditure and fostering competition. For pharmaceutical companies, biosimilars represent both opportunities and challenges, requiring strategic positioning, robust evidence generation, and targeted stakeholder engagement to achieve uptake in markets where prescriber trust and payer confidence are critical.
