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.
You may also be interested in...
US FDA sees role for postmarketing data to help address residual uncertainties and determine additional data needs, but not as basis for securing an interchangeability designation absent a clinical, multi-switching study, draft guidance states.
Brand and generic industries are on opposite sides of spectrum on most issues; there is mutual opposition, however, to the use of a meaningless four-letter suffix in the proper name of a product.
A biosimilar that is not licensed for all of the indications on a reference product's label may still need to include some information about that off-label indication to ensure safe use, draft guidance says.