3^rd World Biosimilars & Biologics Congress

Biosimilars

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. They are developed to have the same mechanism of action, route of administration, dosage form, and strength as the reference product. Biosimilars are not generic drugs, as they are derived from living organisms and their production involves complex manufacturing processes. The introduction of biosimilars in the market can increase competition, potentially leading to reduced costs and increased access to biological therapies for patients. Despite their similarities, biosimilars and their reference products may have minor differences in inactive components.