What They Are
A biosimilar, or follow-on biologic, is a successor to a biologic medicine that has lost patent protection or exclusivity. Due to their relative complexity, something they share with all biologic drugs, biosimilars represent a separate regulatory class of medicines to small-molecule generics.Biosimilars are biologics, and are approved via stringently defined regulatory pathways on the basis that they have demonstrated comparability (high similarity) to their reference product. To win approval, they need to demonstrate both a highly analogous structure (via robust analytical characterization) and comparable quality, safety, and efficacy (via appropriate clinical trials).
Biosimilars can be approved in the same indications as the reference product provided that the mechanism of action is equivalent for all indications. They are recognized around the world as safe and effective medicines. “Alternative biologics”, follow-on versions of existing products that have been approved in local markets but not according to stringent regulatory pathways in highly regulated markets, are – by definition – not biosimilars.
