Biosimilars approved in New Zealand

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Biosimilars approved in New Zealand

Biosimilares/General | Posted 02/05/2014 0 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).

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