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.
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
Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting
The review does not include North America, the healthcare giant said.
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
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
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
The documents acknowledge biosimilars and branded biologics will differ and set assessment standards.
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's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.
Merck funds protein-degrading technology; Shire expects approval for a new ADHD medication in 2017; state biosimilar notification laws focus on subtext
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
Celltrion expects its Remicade biosimilar to hit the US this year; Vivus cuts its sales force; BMJ accuses Novartis of interfering with clinical trials
An Alliance for Safe Biologic Medicines survey shows what doctors mean by biosimilar transparency.
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
Reactions to the first biosimilar approval show that marketing and education will be essential for the new category to take market share.
The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.
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.
A study by the nonprofit research group found resistance to drug switching.
The EU will have access to the new medication in May.
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 said the $17-billion decision to acquire Hospira will not affect the timeline of its divide-or-stay-whole decision.
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.
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.
The committee is slated to rule on Sandoz's Zarzio Jan 7.
As courts sort out lawsuits over two Sandoz biosimilars, the Novartis unit reports a study showing its BLA candidate has similar efficacy to Neupogen.
The company says ABP 510 hit its primary endpoint in an adalimumab comparison.
Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.
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.
A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.
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.
A wave of more effective anti-cancer drugs has set the oncology world on fire with enthusiasm. While many hail this as a new era, an equally vocal faction questions the money spent for the value gained. This medical and commercial trend report for marketers of anti-cancer modalities touches on many of the latest shifts that have expedited product launches and otherwise impacted promotion and reimbursement of these drugs. Click here.