Sandoz: An Interchangeability Labeling Requirement Should Apply To All Biologics

August 31, 2015 at 12:26 PM
Novartis' biosimilar company Sandoz urged FDA to reject "in its entirety" AbbVie's citizen petition asking the agency to require that biosimilar drug labeling contain a clear statement that the product is a biosimilar and that it is licensed for fewer than all the reference product's conditions, among other requests. The move came a few days after AbbVie sent FDA a supplement to its petition reiterating its requests and also objecting to FDA's stance that interchangeability does not have to be...


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