Novartis subsidiary Sandoz asked a US court of appeals to lift the injunction that prevents the company from bringing its newly approved biosimilar Zarxio to market, Reuters reported. The FDA approved Zarxio, a biosimilar of Amgen’s cancer drug Neupogen, in March but Amgen filed a patent-infringement lawsuit and a court granted an injunction last month. Sandoz previously asked that Amgen post a $179.4-million bond as compensation for lost sales.
AbbVie filed a Citizen’s Petition with the FDA asking the agency to require different labels for biosimilars and reference biologics, reported BioCentury, which noted this goes against the regulator’s decision that biologic labels mirror each other. AbbVie’s petition also asks that labels state when biosimilars are not interchangeable with the branded biologic. The requests are similar to the results of a survey released earlier this year of biologic-prescribing doctors.
An FDA panel is reviewing Sprout Pharmaceuticals’ “female Viagra” for the third time on Thursday. FDA staff published documents before today’s meeting indicating that they have concerns about the drug, including how it interacts with alcohol and side effects that include fatigue and fainting.
Sanofi will test its newly approved diabetes drug Toujeo in a real-world setting. The drugmaker said in a statement that the Phase-IV clinical trial will see how Toujeo compares with other basal insulins in a standard-care setting. Sanofi expects results from the 4,500-patient study to be available in 2017.
Opko Health is buying BioReference Laboratories for $1.47 billion in stock, giving Opko rights to genetic data and technology that could enhance efforts in personalized drug development, reported Bloomberg Business.
