We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
Authorities in the UK are urging physicians not to prescribe valproate drugs to pregnant women and to inform women who truly need the drug of potential risks to their unborn children. Read More
Drugmakers and industry groups are urging regulators in Australia to abandon proposed new requirements that call for larger type on drug labels and that labels be made and applied so that they cannot be damaged by opening a product. Read More
An FDA advisory committee may have given its unanimous approval for a biosimilar application this month, but industry and patient groups contend the regulatory pathway still has many potholes and unanswered questions. Read More
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys. Read More
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More