South Korea announced regulatory changes designed to shorten biosimilar review timelines and streamline oversight of manufacturing changes. The reforms also aim to reduce the phase III trial burden by easing clinical trial requirements, according to the coverage. The policy shift targets multiple points in the biosimilar development process—review pacing, trial design expectations, and manufacturing change governance—potentially affecting both local sponsors and international applicants. For biosimilar developers, the key near-term impact is expected to be faster development-to-submission cycles and less complexity around late-stage requirements tied to manufacturing evolution.