Regulation and Corporate Strategy Are Redrawing the Clinical Trial Thresholds for Obesity Drugs, Cell Therapies, and Vaccines
In biopharmaceutical development, the long-standing practice of uniformly relying on large comparative clinical trials in patients is weakening, while review systems that place greater emphasis on precise analysis and pharmacokinetic data are spreading. In Korea, biosimilars that meet certain requirements can be exempted from submitting Phase 3 clinical trial data, and approval and review timelines are also being shortened. At the same time, the trend toward reducing animal testing is entering the regulatory mainstream. China’s regulatory authorities, through the PIONEER program, have officially designated alternative evaluation methods such as organoids, organ-on-a-chip systems, and simulations, showing that the very format of nonclinical data is changing.
2026-08-28