Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate

Stakeholders say an FDA advisory committee meeting in January on the first biosimilar application may offer a key public forum for debate, and a possible first indicator of where the agency is moving on such contentious policy issues as naming and data requirements for products going through the health law's new approval pathway. The panel will take up the agency's review and potential approval of Sandoz's biosimilar of Amgen's Neupogen, and FDA's expected pre-April decision on the product could establish...