Affiliations: Department of Pharmaceutical Technology, Faculty of
Pharmacy, University of the Basque Country, Vitoria-Gasteiz, Spain
Note: [] Corresponding author: B. Calvo, Department of Pharmaceutical Technology,
Faculty of Pharmacy, University of the Basque Country, P. Universidad 7, 01006
Vitoria-Gasteiz, Spain. Tel.: +34 945 013092; Fax: +34 945 013040; E-mail:
b.calvo@ehu.es
Abstract: When a biopharmaceutical product patent expires, other manufacturers
can produce copies of the original drug. These products, called biosimilars
(follow-on biologics in the USA) are similar but not identical to the innovator
drug due to the protein nature complexity. The article reviews the European regulatory basis for biosimilars
approval and marketing. The current situation at USA is also analized as well
as the harmonization perspectives at global level.
