What are biosimilars?
Biosimilars, or follow-on proteins, are new versions of existing biopharmaceuticals whose patents have expired. They are produced using the same core genetic material and are approved on the basis that they are comparable to the reference product in terms of safety and efficacy. They are large, complex molecules produced by living organisms, which are highly sensitive to manufacturing changes; generics are small molecules, produced by chemical synthesis, which are usually very stable. Biosimilars is an official term used by the European medical authorities; the US terminology is follow-on protein products (FOPP).
