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.
Soonish would be good, since a Novartis subsidiary filed a biosimilar with the FDA last month.
Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.
Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.
A three-year, $1 million project seeks an equation for generics and biosimilars.
A London court knocked down two Roche/Genentech patents, making a clearer path for biosimilars of the breast cancer drug. The primary patent lapses in July.
Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.
A court in India ruled biosimilar drug makers will not be able to cite the drug's name, efficacy or safety profile in its marketing.
Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.
The generics maker says an adalimumab biosimilar would anchor its immunology portfolio.
The 2015 healthcare agency questionnaire, for firms hoping to be featured in the Top 100 Agencies issue, is live. Click here to be considered.