Biosimilars: A regulatory review

This article summarizes the regulatory situation of biosimilar medicinal products from their first appearance to the recent approvals and the present situation in the European Union and the United States. The rationale behind the classification of a generic molecule as a biosimilar, comparability, therapeutic equivalence, and substitutability are discussed together with the new opportunities, both for the growth of the generic industry and for the control of national health care expenditure, made possible by biosimilars. The EU's competitive advantage over other countries and its level of preparedness in research, development, and production of biosimilar medicines are also addressed.