Rory Bligh @Datamonitor_RB
I cover biosimilars and generics for Datamonitor Healthcare, with a particular focus on regulatory and legislative affairs. Views expressed are my own. Farringdon Joined May 2013-
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US Trade Rep. pushing for twelve-year biologic exclusivity in TPP talks bit.ly/1dBcHuJ. Likely to benefit some more than others...
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This is likely to be the first in a long line of casualties trying to invalidate the 2028/2029 #Enbrel patents.
Falling at the first hurdle: #Sandoz's Enbrel patent suit is thrown out of court for filing suit without a relevant #biosimilar application.
Ranbaxy files suit against Actavis for generic Absorica application. Patent in question covers use in skin disorders.
FDA criterion would suggest Celltrion are looking to make their biosimilar substitutable. Holy grail for uptake. bit.ly/1asfF2m
Celltrion unveil new #infliximab biosimilar trial, revealing comparable safety and efficacy in patients switched from brand to #biosimilar.
All they need now is to wait a few years for US #biosimilar approvals. And then fifteen for the submarine patent to expire. [2/2]
$Coherus announce positive results in PK study for #Enbrel biosimilar. Meeting EU, US and JP Requirements bit.ly/1aynkIJ [1/2]
Biosimilar update: California governor Brown vetoes the restrictive #biosimilar bill, citing it as premature. bit.ly/19J6nsF
Pick your battles: #FTC drops one no-authorized-generic case a month from starting another: 1.usa.gov/16t1g41, bit.ly/1aHBXKM
The FTC renew commitment to fighting pay-for-delay deals: 1.usa.gov/1a0ig00.
As #Celltrion and Japanese partner Nippon Kayaku announce #biosimilar #Remicade submission in Japan, how long before a US application?
Rory Bligh retweeted
FDA Worried as Calif Passes #Biosimilar #SB 598 "efforts to undermine trust in these products is worrisome" ow.ly/ooyuQ #SB598
Recent #biosimilar bills in California and Delaware both require prescribers to opt out out of substitution. Incentivizing with #nudgetheory
Sham and bad-faith petitions under antitrust scrutiny in new pay-for-delay case around #Solodyn.
Biosimilar development sets a high hurdle as #Lonza scrap #Teva partnership after 'misjudging costs' #biosimilars reut.rs/13f9tCO
#FTC v. #Actavis case likely to be remanded to 11th circuit, which previously ruled pay for delay legal in K-dur case 1.usa.gov/1bJgp38
#FTC to revisit previous #pharma patent settlements to see if they merit further investigation. #payfordelay 1.usa.gov/1bJgp38
Rory Bligh retweeted
US court : Teva loses Copaxone patent suit – Jewish Business News jewishbusinessnews.com/2013/07/17/us-…
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