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Letter to the Editor

Editor, -The Generic Medicines Industry Association wishes to comment on the editorial 'Biosimilars are not (bio)generics' (Aust Prescr 2009;32:146-7) by Professor McKinnon and Dr Lu.

The authors raise several key issues surrounding the important introduction of quality cost-effective 'biosimilars'. Many of the concerns raised are equally pertinent to the originator biologic reference products, and so are neither new nor unique to 'biosimilars'.

Of note, there exists a broad spectrum of 'biosimilar' medicines, ranging from small unglycosylated proteins (for example filgrastim) - which can be extremely well characterised - to much larger molecules (for example monoclonal antibodies) that currently are more difficult to characterise. Therefore, as with all pharmaceuticals, each product should be assessed on a case by case basis, and not be subject to conclusions based on broad generalisations.

It is critical to appreciate that very high levels of data are demanded by regulatory agencies for establishing the quality, safety and efficacy of all 'biosimilars'. These include product characterisation, comparative trials between the 'biosimilar' and the originator, and robust post marketing surveillance plans.

It is well acknowledged that the Therapeutic Goods Administration is the competent authority to determine on every occasion whether these criteria are met, and there is no reason in the case of 'biosimilars' to believe or suggest otherwise.

Kate Lynch
Chief Executive Officer
Generic Medicines Industry Association

Authors' comments

Professor R McKinnon and Dr C Lu, authors of the article, comment:

The comments by the Generic Medicines Industry Association are welcome and we generally endorse the views expressed. We would, however, note that the emphasis of our editorial was deliberately on contrasting biosimilars with generic products based on traditional small chemical entities, rather than on a detailed comparison of biosimilar approval processes with those relating to the approval of the originator biological reference products.