On September 25, 2019, Tanvex BioPharma announced that it received a complete response letter from the U.S. FDA indicating that Tanvex’s abbreviated Biologics License Application (aBLA) for its proposed filgrastim biosimilar, TX01, was not in condition for approval. Tanvex reported that FDA “did not request additional clinical data or express concern related to product safety,” but there were “certain items that need to be addressed before the application can be approved.” Its press release indicated that FDA’s target review cycle for resubmissions is six months.
