A biosimilar is a biological product that is highly similar to an already approved reference biologic in terms of quality, safety, and efficacy, with no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, or immunogenicity. Biosimilars are developed following patent expiry of the originator product and require dedicated comparability studies and regulatory approval by agencies such as the European Medicines Agency (EMA) or Food and Drug Administration (FDA).
