Society and culture Etanercept

1 society , culture

1.1 marketing
1.2 sales
1.3 patents

society , culture
marketing

in north america, etanercept marketed amgen under trade name enbrel in 2 separate formulations, 1 in powder form, other pre-mixed liquid. wyeth [now part of pfizer] sole marketer of enbrel outside north america excluding japan takeda pharmaceuticals markets drug.

sales

the u.s. retail price of enbrel has risen on time. in 2008, cost of enbrel reported $1,500 per month or $18,000 per year. 2011, cost had reportedly exceeded $20,000 per year. in 2013, survey international federation of health plans (ifhp) found average u.s. cost enbrel $2,225 per month, or $26,700 per year. ifhp report found wide variation in prices charged various u.s. health plans, between $1,946 per month @ 25th percentile , $4,006 per month @ 95th percentile.

enbrel more expensive in u.s. in other countries. of 2013, average monthly costs in surveyed nations ranged $1,017 in switzerland $1,646 in canada, compared average monthly cost of $2,225 per month in u.s.

amgen sells enbrel within u.s. , canada, while pfizer, inc. sells drug outside of u.s. , canada. sales within u.s. , canada $3.5 billion in 2010. sales of enbrel outside u.s. , canada $3.3 billion in 2010.

patents

the patent on enbrel set expire on october 23, 2012, but, in united states, second patent, granting exclusivity 16 years, has been granted. before extension seemed unlikely generic have been available. biologic, etanercept subject different laws applicable chemical formulations. many countries not permit manufacture of generic biologics. however, european union , united states (biologics price competition , innovation act of 2009) have in place system approve generic biologics (biosimilars) requires mandatory clinical testing , periodic review .

in april 2013, indian pharma major cipla made announcement launching first biosimilar of etanercept in india under brand name etacept treatment of rheumatic disorders. company s april 17, 2013 press release claimed biosimilar cost 30% less compared innovator.

in january 2015, samsung , biogen s joint venture samsung bioepis submitted benepali, biosimilar version of drug, review european medicines agency (ema), , announced seek regulatory approvals in other territories well. later same year, european medicines agency accepted sandoz’s application review of etanercept product marketed novartis.

in us, sandoz submitted biologics license application (bla) proposed etanercept product gp2015 in july 2016. upon acceptance of first application process, u.s. fda reviewed data european clinical trials , bio-analytical investigations, demonstrating biosimilarity of gp2015 us-licensed enbrel. sandoz in 2009 tried invalidate patents held hoffman-la roche/immunex , exclusively licensed amgen lost in federal court. sandoz countersued amgen patent infringements related methods of treating psoriasis and/or psoriatic arthritis. case immunex corp. et al. vs. sandoz inc. et al., 16-cv-01118-ccc-jbc (d.n.j.) pending.