Replies to post #92726 on Biotech Values

[DewDiligence]

What became of the Neulasta biosilimar BioGeneriX was developing with the now defunct Neose?

[DewDiligence]

HSP gets EU approval for Neupogen biosimilar:

http://finance.yahoo.com/news/NivestimTM-a-New-Biosimilar-prnews-3089808046.html?x=0&.v=1

Biosimilars in the EU are essentially branded generics, i.e. they are non-substitutable for the original brand and they have to be actively marketed.

HSP’s Neupogen knockoff will be sold under the brand name, Nivestim. It will have to compete with several other Neupogen biosimilars as well as AMGN’s original product, so it probably won’t be a big moneymaker.

[DewDiligence]

Teva, AMGN settle Neupogen/Neulasta-biosimilar litigation in US market:

http://finance.yahoo.com/news/Amgen-Resolves-GCSF-Patent-prnews-1961464439.html?x=0&.v=1

Pursuant to the settlement, Teva agreed that its Neutroval knockoff of AMGN’s Neupogen infringes AMGN’s Neupogen patents 5,580,755 and 5,582,823 and will not launch Neutroval until Nov 2013—one month before the patents expire. Settling for a launch only one month early clearly shows that Teva did not have much confidence in its case.

For Neugranin, a knockoff of Neulasta that Teva acquired in the Ratiopharm deal (#msg-47996297), Teva can continue to litigate the patent; if unsuccessful, Teva can launch in Nov 2013 coincident with the launch of at Neutroval.

The Neutroval and Neugranin applications are supported by their own clinical dossiers using the traditional BLA pathway rather than the new 351(k) pathway for biosimilars.