Replies to post #193514 on Biotech Values

[GrthzGd]

NVS eschewed the apparently mandated 'patent dance' for biosimilars and lost in both lower courts as a result. This case overturns those rulings and says NVS followed the correct approach after all. See Message 111544783 for background.

[DewDiligence]

NVS launches Zarxio (Neupogen FoB) at ~15% price discount:

http://www.wsj.com/articles/novartis-to-begin-selling-copy-of-amgens-neupogen-in-u-s-1441263475

A Novartis spokesman said the company would sell Zarxio at a 15% discount to Neupogen, based on list prices. For example, a 300-microgram syringe of Zarxio would list for $275.77, compared with $324.30 for an equivalent dose of Neupogen.

Zarxio is the first drug approved under the FDA’s 351(k) pathway for FoBs. Although approved by the FDA in Mar 2015, Zarxio couldn’t be launched until now because the US Appellate Court ruled that a 6-month delay was the penalty for NVS’ refusal to participate in the 351(k) “patent dance” process specified in the 351(k) statute (#msg-115571193, #msg-115579876).

[DewDiligence]

Re: FoB patent dance/180-day launch delay

In the AMGN vs Apotex case pertaining to Apotex’s Neulasta FoB, a US District Court ruled that Apotex must furnish 180-day notice of launch after obtaining FDA approval—effectively delaying the FoB launch by 180 days—even though Apotex followed the “patent dance” procedures set forth in the statutes for the 351(k) pathway:

http://www.law360.com/lifesciences/articles/736258

This is a change from the CAFC’s ruling in the Zarxio case (#msg-115571193), where the Court said NVS had to wait 180 days from FDA approval until launching Zarxio as a penalty for not having followed the patent dance procedures, implying that FoB applicants had a choice of whether to adhere to the patent dance or wait 180 days before launching.

US Supreme Court intervention is likely at some point, IMO.