Replies to post #188262 on Biotech Values

[DewDiligence]

Zarxio addendum: NVS might not launch immediately insofar as the patent litigation between NVS and AMGN remains unresolved.

[genisi]

NVS’ Zarxio (NeupogenFoB), the first FDA approval under the 351(k) FoB pathway

Another record for NVS is that Zarzio has already outsold the brand (Neupogen) and is the first biosimilar to do so.

[biotech jim]

<Zarxio/filgrastim-Sandoz

I was talking with a oncologist friend of mine who has her practice at the UW-Madison Healthcare System. She told me that the UW System has decided to use the Novartis filgrastim product almost exclusively going forward. Cost of the Amgen product was the reason. Any idea of the cost differential?

[DewDiligence]

NVS/AMGN/etc—Appellate Court says NVS can launch Zarxio on 9/2/15, despite not engaging in the 351(k) patent-exchange process:

http://www.bloomberg.com/news/articles/2015-07-21/amgen-loses-appeals-court-ruling-in-bid-to-stop-novartis-drug

The 9/2/15 date is 180 days from the FDA approval of Zarxio (#msg-111475426). I.e., if today’s CAFC ruling becomes the precedent for US FoB launches, then FoB sponsors opting not to participate in the 351(k) patent-exchange process will instead be subject to a 180-day delay from the date of FDA approval to the date of launch.

The CAFC’s actual ruling can be found at:
http://t.co/PN85UMcG61