MELBOURNE, Australia, Sept. 26 /PRNewswire-FirstCall/ —
Hospira, Inc. (NYSE:
HSP), the world leader in generic injectable pharmaceuticals,
today announced that it has received Australian Therapeutic Goods
Administration (TGA) approval for its biosimilar filgrastim
product, Nivestim™.
Nivestim has been approved for a range of indications, including
the prevention of febrile neutropenia (FN) and reduction in
duration of chemotherapy-induced neutropenia (CIN). Neutropenia is
the most serious hematological toxicity that occurs as a result of
cancer chemotherapy and can lead to chemotherapy dose reductions
and/or dose delays compared with the prescribed schedule.(1)
Nivestim is the first biosimilar version of Neupogen®
approved in Australia. Neupogen has current sales within Australia
of approximately AUD25 million (U.S. $24 million). Hospira is
working closely with Australian government agencies to ensure
efficient market access for biosimilars, and has submitted an
application to have Nivestim listed on the Australian
Pharmaceutical Benefits Scheme. Listing and product launch are
expected during the first half of 2011.
“Approval of Nivestim, the first biosimilar filgrastim in
Australia, is another important milestone for Hospira as we build
our global biosimilars portfolio,” said Tim Oldham, president, Asia
Pacific, Hospira. “Nivestim will help reduce the cost of providing
this lifesaving therapy across Australia, and includes a unique
combination of administration, storage and safety features that
will enhance safety for healthcare professionals and patients.”
Three pre-filled syringe presentations of Nivestim were approved
in Australia: 300 mcg/0.5 mL, 480 mcg/0.5 mL and a unique 120
mcg/0.2 mL low body weight presentation.
In a large, randomized Phase lll study, Nivestim demonstrated
comparable efficacy to Neupogen in the prevention o
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