The Ministery of Food and Drug Safety said on the 27th it will begin a prior review to ease phase 3 clinical requirements for biosimilars (biosimilar). The move is expected to shorten biosimilar development timelines and expense and speed up overseas expansion.
The National Institute of Food and Drug Safety Evaluation (NIFDS) under the Ministery of Food and Drug Safety released on this day the "guideline on considerations when deciding to conduct comparative efficacy clinical trials of equivalent biological medicines." It explained what needs to be considered in phase 3 clinical trials for biosimilars.
When corporations develop a biosimilar and have secured sufficient equivalence and safety with the original medicine, the guideline sets criteria under which a phase 3 clinical trial does not have to be conducted. This is based on phase 1 results and quality data. The Ministery of Food and Drug Safety plans to revise related approval regulations to apply the easing of phase 3 requirements.
The guideline also includes factors that should be considered for conducting phase 3 trials, as well as various procedures and required documentation. The Ministery of Food and Drug Safety said, "Biosimilar exports will increase and patients will have more opportunities to receive treatment."