The US FDA’s biosimilar labeling final guidance is not likely to upset the apple cart for 351(k) sponsors as it largely retains the principles and recommendations described in a March 2016 draft proposal.
Key among these, the final
Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors
Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.