Biosimilar User Fee Collections Climb; Application Growth Less Clear
Executive Summary
FDA plans to send out 57 invoices for annual biosimilar product development fees in fiscal year 2016, 10 more than were sent last year, but agency remains mum on how many 351(k) submissions it expects.
You may also be interested in...
Biosimilar Pathway Quickly Becoming Crowded In U.S.
Interactive chart of growing 351(k) pipeline shows that while Phase III is dominated by big players, pure-play biosimilar companies are beginning to emerge.
Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update
Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.
Gene Therapy Safety Issues Reflect Pushing Of The Scientific Envelope – FDA’s Marks
Recent adverse events are ‘speed bumps’ that need to be worked around, biologics center head Peter Marks says; Morgan Stanley’s Peter Hwang asserts high-profile safety issues have added to unpredictability of gene therapy development, dampening investor enthusiasm for the field.