Morgan Lewis partner Stephen Paul Mahinka will be a panelist at the roundtable discussion on labeling issues at the upcoming FDLI conference, Biosimilars Naming and Labeling.
Some the issues to be discussed include:
- Should the biosimilar package insert identify the product as a biosimilar and what should it say about the significance of this status?
- How should the package insert convey the indications approved and the basis for their approval?
- Should "carve outs" be permitted? How should such "carve outs" be handled?
- Which studies should be described in the biosimilar package insert?
- Can and/or should FDA address substitution and switching through labeling, where the product is not interchangeable?
- How should FDA and the reference product and biosimilar sponsor handle postmarket data and new developments (with respect to either product) after a finding of biosimilarity and/or interchangeability?
Wednesday, November 16, 2011
1111 Pennsylvania Ave., NW
Washington, DC 20004