The FDA is set to announce its decision on the drug in April.
SEC is investigating Salix Pharmaceuticals; FDA adcomm recommends approval of Remicade biosimilar; Medicare considers payment changes
The FDA to review biosimilar Remicade; lawmaker looks at panelists' ties to painkiller manufacturers; Novartis signs risk-sharing contracts for Entresto
Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog
The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges
Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday
Keytruda approved in non-small cell lung cancer; Enbrel biosimilar inches closer to approval; study finds no link between autism and vaccines
Sandoz plans to take a branded approach as it launches the first FDA-approved biosimilar product.
Novartis launches Zarxio, the first US biosimilar; UCB sells its generic business; one-third of children with ADHD are diagnosed before they turn six
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.
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.
Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed
Johnson & Johnson CEO Alex Gorsky said physicians are unlikely to switch the majority of patients to a biosimilar version of Remicade.
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.