Generic and Biosimilar Medicinal Products in the European Union

The recent revisions of the Community Codes on Medicinal Products introduced a number of changes to the procedure for granting marketing authorisation for generic medicinal products, both human and veterinary. Among the changes are the introduction of a process for authorisation of “biosimilar” products. The term "biosimilar" is perceived in some corners as an acknowledgement of the fact that it is not possible to produce a generic version of a biotechnology product. This article examines how the authorisation process for biosimilars has operated in practice in its first year of application.

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