Biosimilars

With support of FDA committee, Remicade biosimilar edges closer to market

With support of FDA committee, Remicade biosimilar edges closer to market

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The FDA is set to announce its decision on the drug in April.

Five things for pharma marketers to know: Wednesday, February 10, 2016

Five things for pharma marketers to know: Wednesday, February 10, 2016

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SEC is investigating Salix Pharmaceuticals; FDA adcomm recommends approval of Remicade biosimilar; Medicare considers payment changes

Five things for pharma marketers to know: Tuesday, February 9, 2016

Five things for pharma marketers to know: Tuesday, February 9, 2016

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The FDA to review biosimilar Remicade; lawmaker looks at panelists' ties to painkiller manufacturers; Novartis signs risk-sharing contracts for Entresto

Five things for pharma marketers to know: Friday, February 5, 2016

Five things for pharma marketers to know: Friday, February 5, 2016

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Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog

Five things for pharma marketers to know: Thursday, December 17, 2015

Five things for pharma marketers to know: Thursday, December 17, 2015

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The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges

Five things for pharma marketers to know: Wednesday, November 18, 2015

Five things for pharma marketers to know: Wednesday, November 18, 2015

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Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday

Five things for pharma marketers to know: Monday, October 5, 2015

Five things for pharma marketers to know: Monday, October 5, 2015

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Keytruda approved in non-small cell lung cancer; Enbrel biosimilar inches closer to approval; study finds no link between autism and vaccines

Sandoz: Zarxio marketing to be similar to a branded-drug launch

Sandoz: Zarxio marketing to be similar to a branded-drug launch

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Sandoz plans to take a branded approach as it launches the first FDA-approved biosimilar product.

Five things for pharma marketers to know: Thursday, September 3, 2015

Five things for pharma marketers to know: Thursday, September 3, 2015

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Novartis launches Zarxio, the first US biosimilar; UCB sells its generic business; one-third of children with ADHD are diagnosed before they turn six

Judge's ruling allows Sandoz to begin marketing its biosimilar Zarxio

Judge's ruling allows Sandoz to begin marketing its biosimilar Zarxio

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The motion denied Amgen's bid for a temporary injunction that would have prevented the launch of Zarxio, the first FDA-approved biosimilar and a competitor to Amgen's Neupogen.

Most docs are in the dark about biosimilars: survey

Most docs are in the dark about biosimilars: survey

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Less than half of 300 doctors polled in a QuantiaMD survey could name a biosimilar that's under consideration for approval, and only 17% said they're very likely to prescribe one.

Five things for pharma marketers to know: Wednesday, July 22

Five things for pharma marketers to know: Wednesday, July 22

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Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed

J&J prepares to defend Remicade market share

J&J prepares to defend Remicade market share

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Johnson & Johnson CEO Alex Gorsky said physicians are unlikely to switch the majority of patients to a biosimilar version of Remicade.

Pharmacy groups urge consistent naming of biosimilars

Pharmacy groups urge consistent naming of biosimilars

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The health insurance industry's trade association, along with other organizations, sent a letter to the FDA arguing that different names could lead to prescriber confusion and medication errors.

Five things for pharma marketers to know: Wednesday, June 10

Five things for pharma marketers to know: Wednesday, June 10

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FDA panel recommends Sanofi/Regeneron's PCSK9 inhibitor for approval; Merck and Samsung collaboration says their rheumatoid arthritis biosimilars are equivalent to the biologic versions; Bayer offloads its diabetes-care business

Five things for pharma marketers to know, Thursday, June 4

Five things for pharma marketers to know, Thursday, June 4

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Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting

J&J puts global media business up for review

J&J puts global media business up for review

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The review does not include North America, the healthcare giant said.

Five things for pharma marketers to know: Thursday, May 14

Five things for pharma marketers to know: Thursday, May 14

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An economist wants $37 billion invested in antibiotic development; Roche plans to file an experimental lung-cancer drug with the FDA this year; Sandoz wants compensation for lost Zarxio sales

Five things for pharma marketers to know: Thursday, May 7

Five things for pharma marketers to know: Thursday, May 7

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A court halted the launch of Sandoz's biosimilar; GSK said it is concerned about Advair competition in the US; an FDA panel is expected to vote on a female sexual disorder drug

Five things for pharma marketers to know: Friday, May 1

Five things for pharma marketers to know: Friday, May 1

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Nexium tops the list of Medicare's spending on brand drugs; Gilead Sciences doubles its first-quarter profit; Pfizer reportedly wants to buy a rare-disease drug company

FDA finalizes biosimilar guidance

The documents acknowledge biosimilars and branded biologics will differ and set assessment standards.

Five things for pharma marketers to know: Wednesday, April 22

Five things for pharma marketers to know: Wednesday, April 22

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Study finds vaccines still not linked to autism; investments in healthcare start-ups hit record high this year; biosimilars are already bearing down on prices overseas

Amgen motion to delay Neupogen biosimilar denied

Amgen's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.

Five things for pharma marketers to know: Tuesday, April 7

Five things for pharma marketers to know: Tuesday, April 7

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Merck funds protein-degrading technology; Shire expects approval for a new ADHD medication in 2017; state biosimilar notification laws focus on subtext

Five things for pharma marketers to know: Friday, April 3

Five things for pharma marketers to know: Friday, April 3

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Hedge fund activist challenges Shire patents; CMS issues documents on biosimilars; Astellas Pharma and the University of Texas MD Anderson Cancer Center partner on leukemia treatment

Five things for pharma marketers to know: Thursday, April 2

Five things for pharma marketers to know: Thursday, April 2

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Celltrion expects its Remicade biosimilar to hit the US this year; Vivus cuts its sales force; BMJ accuses Novartis of interfering with clinical trials

Doctors want specifics on biosimilar labels

An Alliance for Safe Biologic Medicines survey shows what doctors mean by biosimilar transparency.

Five things for pharma marketers to know: Friday, March 20

Five things for pharma marketers to know: Friday, March 20

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A judge rules against Amgen in Neupogen case; FDA advisory panel recommends Breio Ellipta for adults with asthma; AstraZeneca partners with Daiichi Sankyo to sell Movantik

Biosimilar uptake will require companies to tell a trustworthy backstory

Biosimilar uptake will require companies to tell a trustworthy backstory

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Reactions to the first biosimilar approval show that marketing and education will be essential for the new category to take market share.

FDA hands Amgen a biosimilar competitor

FDA hands Amgen a biosimilar competitor

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The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.

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