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Implications of Nivestim’s approval on the Australian biosimilars market

6 Oct 2010, by Informa Insights

Melbourne – 6th October 2010 – Biosimilars in Australia: Nivestim approval opens up local filgrastim biosimilars market.

Lisette Oversteegen, Lead Analyst, comments:

“Although the recent approval of biosimilar filgrastim is a positive development for the Australian industry, the proposed biosimilars pricing regulations may slow uptake”.

Compared with Europe, where several biosimilar products of three different molecules (epoetin, filgrastim and somatropin) have been approved since 2006, Australia’s biosimilars market is still very small. Until recently, somatropin was the only biologic that had biosimilar versions available, according to a new report by Datamonitor*. Furthermore, “Sales in this market were low at $45,000 in 2009,” states Datamonitor Lead Analyst Lisette Oversteegen, “and still very much dominated by Pfizer’s branded somatropin products Genotropin and Genotropin MiniQuick.”

Last month, however, the Australian Therapeutic Goods Administration (TGA) granted approval to a new class of biosimilars, with the authorization of Nivestim (filgrastim; Hospira). Having already gained successful marketing approval from the European Medicines Agency (EMA) in June 2010, and listed on the agenda for Australian reimbursement consideration in November, Nivestim is expected to enter the Australian market in early 2011. It will compete with the original brand Neupogen (filgrastim; Amgen), which had sales of $21m in 2009 in Australia. It is interesting to note that Nivestim is the first filgrastim biosimilar to be launched in Australia, despite the fact that others have been available in key biosimilar markets such as Germany for some time, including Biograstim (CT Arzneimittel GmbH) and Ratiograstim (Ratiopharm).

“Although the approval of Nivestim is a positive development for the Australian biosimilars industry, the proposed biosimilars pricing regulations may slow uptake,” comments Oversteegen. In July 2010, the TGA and Pharmaceutical Benefits Division (PBD) published a consultation paper on potential biosimilars pricing regulations. “Some of the government’s proposals will come as a disappointment to companies planning to launch biosimilars in Australia”, states Oversteegen.

One of the key limitations will be a likely ban on ‘a’-flagging, which is currently used to indicate equivalent drugs on the Pharmaceutical Benefits Scheme (PBS) and allows pharmacists to automatically substitute an innovator brand with a generic without seeking prescriber permission. As in Europe, a ban on automatic substitution with biosimilars would require substantial sales and marketing investment from biosimilar manufacturers and would slow their uptake. The discussion paper also proposes that biosimilars that received marketing approval based on an abridged application dossier and with the same non-proprietary name as the innovator brand (indicating that they are biosimilars to this innovator brand) will, upon approval for reimbursement, be placed on the F2 formulary. This means that biosimilars and reference products will be subject to F2 statutory price reductions and the price disclosure scheme, as detailed in the Memorandum of Understanding (MoU) agreed earlier this year between the government and Medicines Australia.

On the other hand, a driver of the biosimilars market in Australia is the fact that the TGA has adopted a number of European Union (EU) guidelines, including many biotechnology and biological guidelines. The EU has led the way in developing a legal basis for evaluating and approving biosimilar products and the Australian biosimilars industry is certain to benefit from the fact that the TGA is likely to follow the EMA guidelines. Furthermore, many biosimilars manufacturers are keen to test the water with less complex biosimilars, like somatropin and filgrastim, before attempting to enter the market through a more complex and risky pathway for biosimilar monoclonal antibodies. The launch of Nivestim may therefore open the door for a plethora of other filgrastim biosimilars to become available in Australia.

“Based on the recent progress around approval guidelines for more profitable monoclonal antibodies in Europe and Nivestim’s approval in Australia, Datamonitor expects other biosimilars producers to seek approval for their filgrastim biosimilars in Australia, making this market segment more competitive in the long term,” Oversteegen concludes.

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