The past five years have witnessed a growth in the development of specific guidelines for biosimilar products by different regulatory authorities worldwide. The guidelines established in the European Union in 2005 underwent significant revisions in 2013, with the main goal of facilitating the global development of biosimilars. The World Health Organisation (WHO) published its own guidelines in 2009 and these, together with the European provisions, are being used as a reference in many countries.
This article focuses on the latest challenges impacting the global clinical development of biosimilar products. For regulatory professionals, early awareness and a quick reaction to change in a wide range of national laws, including interchangeability, substitution and implementation of technology-transfer legislation, could help developers to move faster into key markets.
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