Biosimilar Labeling: Should FDA Just Throw Up Its Hands And Finalize Guidance?

 
• By Michael Cipriano

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.

The zero hour for the comment submissions on the biosimilar labeling draft guidance has passed, with both innovator and generic drug groups pulling FDA in opposite directions over issues related to the inclusion of clinical data and the agency's proposed statement on biosimilarity.

With the last string of industry comments coming in by the Aug

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