Hospira's Nivestim receives Australian TGA approval

Sep 27 2010

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.

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 of FN, and was as well tolerated, with a similar adverse event profile.

Nivestim is Hospira's second biosimilar and first in Australia. The company's biosimilar erythropoietin, Retacrit™, is currently available in 17 European countries, and Nivestim was approved by the European Commission in June 2010.