Biosimilar Development Time and Costs to Be Reduced... Phase 3 Clinical Trial Requirements Eased

MFDS to Waive Data Submission if Quality and Pharmacokinetic Equivalence Are Demonstrated
Partial Exemption from Animal Testing Also Allowed

The government has launched regulatory reforms to ease requirements for submitting data from Phase 3 clinical trials and certain animal studies during the development of biosimilars (biologic drugs with equivalence). The measure is intended to reduce unnecessary clinical burdens by aligning with global regulatory standards, while supporting domestic bio companies in their product development and global market expansion.

The Ministry of Food and Drug Safety announced on the 14th that it would revise and implement the “Regulation on Approval and Review of Biological Products,” which rationalizes the requirements for submission of Phase 3 clinical trial and animal study data for biosimilars. This revision is a follow-up to the “Bio Innovation Forum” presided over by the President in September last year. The Ministry has operated a “Biosimilar Clinical Reform Public-Private Council” with industry stakeholders to prepare plans for institutional improvement.

First, requirements for submitting data necessary for biosimilar development have been eased. Previously, biosimilar approval required submission of both Phase 1 (pharmacokinetic) and Phase 3 clinical trial data. Now, if quality, non-clinical testing, and pharmacokinetic equivalence are sufficiently demonstrated, submission of Phase 3 clinical trial data will no longer be mandatory.

In addition, following the global regulatory trend to reduce animal testing, biosimilar developers may be exempted from submitting repeated-dose toxicity study data if the quality and pharmacological equivalence of the biosimilar are confirmed.

The Ministry of Food and Drug Safety has already published guidelines detailing the factors that should be considered when determining whether to conduct Phase 3 clinical trials for biosimilars. Since March, the Ministry has also operated a pre-review system that allows companies to discuss in advance whether a clinical trial is required.

A Ministry official stated, “With this revision, the development time and costs for biosimilars will decrease, thereby helping to strengthen the global competitiveness of domestic companies,” and emphasized, “We will continuously pursue regulatory innovation based on scientific evidence and safety.”

This content was produced with the assistance of AI translation services.