Biotech Values

[DewDiligence]

HSP gets Australian approval for Neupogen biosimilar, Nivestim:

http://finance.yahoo.com/news/Hospira-Receives-TGA-Approval-prnews-1546824801.html?x=0&.v=1

Nivestim, which was approved in the EU in Jun 2010 (#msg-51176267), is HSP’s second biosimilar product; the first is a knockoff of Epogen called Retacrit that is was approved in the EU in 2008.

Other Neupogen biosimilars in Europe are NVS’ Zarzio (#msg-52296278) and Teva’s TevaGrastim and RatioGrastim.

In the US, Teva has submitted a conventional BLA (i.e. not an abbreviated BLA under the FDA’s new regulatory pathway for FoB’s) for a Neupogen knockoff called XM102, which is essentially the same drug as TevaGrastim.