Bioanalysis Zone

Chapter 1: Current regulatory landscape for biosimilars approval

This entry is part 3 of 10 in the series Bioanalysis for Biosimilars Development

Doi: 10.4155/FSEB2013.14.103


Begoña Calvo
Professor of Pharmacy
Pharmaceutical Technology Department
Faculty of Pharmacy. University of the Basque Country
P. Universidad, 7
01006 Vitoria-Gasteiz, Spain.
Tel.: +34 945 013092
Fax: +34 945 013040

About the Author

Professor Begoña Calvo is presently holds the role of Professor of Pharmacy at the University of the Basque Country (Vitoria-Gasteiz, Spain). She was awarded her Ph.D. in Pharmacy (extraordinary award) at the University of Salamanca (Salamanca Spain) in 1985. She specializes in hospital pharmacy, and in drug analysis and control. She was also the director of the Ph.D. program ‘Drug evaluation and research’ The University of the Basque Country (UPV/EHU).

Begoña Calvo has made significant contribution to the field of PK, drug delivery and biopharmaceuticals regulation, having authored over 80 peer-reviewed articles. She is also the author of several book chapters and of three books. She has participated in over 150 national and international conferences over the years and has also supervised several Ph.D. dissertations

She reviews articles for several scientific journals, such as Trends in Biotechnology, Pharmacoepidemiology and Drug Safety, Journal of Clinical Pharmacology and Regulatory Toxicology and Pharmacology.

She is a member of several scientific societies (e.g., European Society of Clinical Pharmacy, American College of Clinical Pharmacy, Spanish Pharmaceutical Care Foundation, and Spanish Society of Pharmaceutics and Pharmaceutical Technology) and was a fellow at the Mario Negri Institute for Pharmacological Research (Italy) between 1987 and 1988.

Since 2008, she has been involved in the evaluation of Masters programs as a member of the Verification Committee of the Spanish National Agency for Quality and Authorization (ANECA).

Current regulatory landscape for biosimilars approval


When the license of a biotechnological drug expires, other manufacturers can produce copies of the original drug. These products, called ‘biosimilars’ in the European Union (EU), are biological drugs similar, but not identical, to the innovator drug. As is well known, biosimilars cannot be considered generic drugs, since they are not exact copies of the original drug due to the complexity of its protein nature. Their approval is based on an extensive comparability exercise at quality, preclinical and clinical levels. “The posology and route of administration of the biosimilar should be the same as that of the reference medicinal product. Deviations from the reference product as regards formulation or excipients require justification or further studies” [1].

This chapter reviews the worldwide regulatory framework for biosimilars with special emphasis on European regulations. Comparison of the regulatory requirements and some recommendations regarding global harmonization will be provided.

European guidelines for developing biosimilar drugs

Europe was the first region to establish a regulatory framework for the manufacturing and approval of biosimilars. The concept of ‘biosimilarity’ for the manufacturing approval of similar versions of innovative products in the EU was introduced in 2003 through the implementation of two European Directives [2,3] amending

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