On October 30, we reported on the FDA’s decision to release a draft guidance that would obviate the need for late-stage, comparative efficacy studies for most biosimilar candidates. We brought up the question of timing, in that for some very high-profile biologic targets, phase 3 studies were already underway. The removal of a phase 3 … Continue reading Phase 3 Trials Already Being Reconsidered by Manufacturers for Keytruda and Opdivo Biosimilars