In Mexico, Asbroder™ (imiglucerase; Abcertin™ in other countries) has been approved for the treatment of GD, but it does not meet the exact definition of a biosimilar described by the World Health Organization (WHO) and other international guidelines. However, it was recognized as an orphan drug for GD and approved by the sanitary authority in Mexico with the same international non-proprietary name (imiglucerase), in order to increase national access to treatment. This regulatory practice opens up a debate surrounding the relationship between international guidelines, clinical medicine, scientific evidence, bioethical considerations, public health institutions, and local laws. The aim of this paper is to establish whether there are biosimilars of imiglucerase as a therapeutic option. Moreover, it describes the regulatory setting of non-originator biological drugs in orphan diseases based on the approval of the non-originator imiglucerase in Mexico.
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