In a move that is bound to be as controversial as any other in the field of biosimilars, the FDA yesterday released draft guidance for industry about the labeling of biosimilar products that innovator product data can now be used, in part, for biosimilar labeling.
Some manufacturers want to include information from the clinical data for the biosimilar rather than the innovator product data. In addition, there were concerns that the label for Zarzio (Sandoz), the first