Medsafe defines a biosimilar as a new biological product that is similar to another biological medicine that has been granted consent to be marketed in New Zealand (the biological reference).

Medsafe does not cite any specific New Zealand guidelines for biosimilars, but refers biosimilars manufacturers to both the US Food and Drug Administration draft guidelines and the European Medicines Agency guidelines for more information.

The first biosimilar to receive approval in New Zealand was Hospira’s neutropenia (low white blood cell) treatment Nivestim (filgrastim) in May 2012. To date, Medsafe has approved four biosimilars within the product classes of erythropoietin, human growth hormone and granulocyte colony-stimulating factor, for use in New Zealand, see Table 1.

Table 1: Medsafe approved biosimilars*

Related article

Biosimilars approved in Europe

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. New Zealand guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 2]. Available from: www.gabionline.net/Guidelines/New-Zealand-guidelines-for-biosimilars

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