Biosimilars

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.

Five things for pharma marketers to know: Friday, March 6

Five things for pharma marketers to know: Friday, March 6

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FDA approves the first biosimilar, judge rules that FDA panel members had conflicts of interest, and a new venture will evaluate the effectiveness of digital health technologies.

Tufts: biosimilars will not be an instant hit

A study by the nonprofit research group found resistance to drug switching.

Lilly Lantus biosimilar to hit EU

The EU will have access to the new medication in May.

Five things for pharma marketers to know: Monday, February 9

Five things for pharma marketers to know: Monday, February 9

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Achillion's experimental HCV drug cleared the virus in six weeks when combined with Gilead's Sovaldi; Sanofi will replace a third of its sales managers; GSK shutters Montana vaccine R&D.

Pfizer's Hospira deal shores up established product division

Pfizer's Hospira deal shores up established product division

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Pfizer said the $17-billion decision to acquire Hospira will not affect the timeline of its divide-or-stay-whole decision.

Five things for pharma marketers to know: Wednesday, February 4

Five things for pharma marketers to know: Wednesday, February 4

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One in three adults would rather not take a pill and have a shorter life span; Pfizer's next-gen breast-cancer drug nabs an early approval; Amgen's Humira biosimilar demonstrates clinical equivalence.

Five things for pharma marketers to know: Tuesday, January 20

Five things for pharma marketers to know: Tuesday, January 20

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FDA draws fine line between health and wellness apps; Colorado gives biosimilar swap law another look; ZMapp is set to start human trials of its Ebola vaccine.

FDA panel to weigh first biosimilar application

FDA panel to weigh first biosimilar application

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The committee is slated to rule on Sandoz's Zarzio Jan 7.

FDA plans review of Sandoz's Neupogen biosimilar

As courts sort out lawsuits over two Sandoz biosimilars, the Novartis unit reports a study showing its BLA candidate has similar efficacy to Neupogen.

Amgen releases Humira biosimilar data

The company says ABP 510 hit its primary endpoint in an adalimumab comparison.

FDA kind of OKs Lilly/BI's Lantus look-alike

FDA kind of OKs Lilly/BI's Lantus look-alike

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Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.

Doctors back unique biosimilar names

A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.

Investors want end to biosim trash talk

A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.

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What does going "beyond the pill" actually mean? At MM&M's recent inaugural spring conference, audience members heard from real-world companies that are managing the organizational, technological, and promotional challenges inherent in this transition, such as partnering with health neophytes, harnessing technologies that allow deeper engagement with patients, and adopting a new commercial mindset to serve, not sell. Download here.


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