Biosimilars approved in New Zealand

Biosimilars/General | Posted 02/05/2014 post-comment0 Post your comment

Last update: 2 May 2014

In New Zealand, the regulatory body for the approval of medicines, including biosimilars, is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

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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*

Product name Active substance Therapeutic area Authorization date Manufacturer/ Company name
Binocrit epoetin alfa Anaemia
Renal anaemia
27 Feb 2013 Novartis
Nivestim filgrastim Cancer
Haematopoietic stem cell transplantation
Neutropenia
24 May 2012 Hospira
Omnitrope somatropin Pituitary dwarfism
Prader-Willi syndrome
Turner syndrome
Nov 2013 Novartis
Zarzio filgrastim Cancer
Haematopoietic stem cell transplantation
Neutropenia
31 Mar 2014 Novartis
*Data collected on 2 May 2014
Source: Medsafe

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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Source: Medsafe

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