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Amgen is suing Sandoz to stop the French drugmaker from marketing a biosimilar of its top-selling product Neupogen in the U.S., charging that Sandoz didn’t follow the rules for biosimilar development. Read More
Manufacturers seeking approval of biosimilars in Europe will be able to use comparator biologics authorized outside the EU to gain marketing clearance. Read More
The FDA approved under its breakthrough therapy designation pathway Pfizer’s meningitis vaccine Trumenba, the first vaccine to prevent a deadly strain of meningococcal disease. Read More
Manufacturers of forthcoming biosimilars argue that their products should have the same international non-propriety name (INN) as the reference product, and do not need a unique qualifier to distinguish them from the brand version for the purposes of tracking. Read More
Generic drugmakers want the FDA to better define what qualifies for a “controlled correspondence” under a draft guidance that aims to speed agency responses to manufacturer queries. Read More
Drugmakers are split on whether the FDA should establish a program to reserve proprietary product names, with some calling for a new fee-based system and others recommending ways to improve the current process that has derailed applications with late-stage name rejections. Read More
The FDA has made progress addressing its looming ANDA backlog, assigning 65 percent of the languishing applications a targeted action date, say top agency officials, who add that new generic drug review processes will improve response rates going forward. Read More
The FDA wants to improve the way it communicates with sponsors of investigational new drug applications and is seeking industry and academia’s advice on how to accomplish that goal. Read More