Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors

19 Jul 2018

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.

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 guidance stands by the agency’s earlier conclusion that biosimilar labeling generally should not include...