FDA to Tackle Industry Concerns in First Biosimilars Meeting

The FDA may end its silence on how an approval pathway for biosimilars will work once it gets feedback at its first public meeting on the topic next month. The meeting, which will be held Nov. 2 and 3, will address several of industry’s most pressing questions since the creation of the pathway earlier this year. Issues slated for discussion include what it will take for a product to be deemed “interchangeable” and how a biosimilars user fee program should be structured, the FDA says in a Federal Register notice.
Drug Industry Daily