By Soon-ho Lee

Health Korea News

SEOUL, South Korea, July 14, 2026 — South Korea's Ministry of Food and Drug Safety (MFDS) has introduced regulatory reforms that allow biosimilar developers to waive the submission of confirmatory Phase 3 clinical trial data under certain conditions, a move aimed at accelerating product development and strengthening the global competitiveness of the country's biopharmaceutical industry.

The revised Regulation on Approval and Review of Biological Products took effect on July 14. The measure follows a government-led biotechnology innovation initiative discussed during a presidential meeting in September last year and is designed to rationalize regulatory requirements while maintaining standards for product quality, safety and effectiveness.

Under the previous regulatory framework, biosimilar applicants were generally required to submit both Phase 1 and Phase 3 clinical trial data to demonstrate comparability with the reference biologic.

However, under the revised regulation, therapeutic confirmatory clinical trial data may no longer be required if a biosimilar has sufficiently demonstrated comparability with the reference product through quality assessments, non-clinical evaluations and pharmacokinetic (PK) studies.

The MFDS also eased requirements related to animal testing. Repeat-dose toxicity study data may be exempted when developers demonstrate sufficient quality and pharmacological comparability with the reference product, reducing unnecessary animal studies during biosimilar development.

The key changes were introduced through newly established provisions under Articles 23 and 24 of the Regulation on Approval and Review of Biological Products, which clarify the scope of required submission data and the conditions for exemptions.

Under Article 23, biosimilar applicants may be exempted from submitting therapeutic confirmatory clinical trial data if quality, non-clinical and PK comparability with the reference product has been established.

The revised regulation also includes an exception allowing developers to be exempted from submitting PK study data when such studies are scientifically or technically impossible, provided that therapeutic confirmatory clinical trial data are submitted instead.

In addition, Article 24 allows exemptions from repeat-dose toxicity study data requirements when quality and pharmacological comparability have been demonstrated, helping minimize unnecessary animal testing.

The MFDS has operated a pre-review consultation system since March to allow companies to discuss in advance whether Phase 3 confirmatory trials are necessary for their biosimilar development programs. The agency has also published related guidance to support developers.

The regulatory reform is expected to shorten development timelines and reduce clinical development costs for biosimilar manufacturers, potentially helping Korean companies expand their presence in global markets.

The MFDS said it will continue pursuing science-based regulatory innovation while ensuring rigorous standards for the quality, safety and effectiveness of biological products.

The detailed information on the revised regulation is available through the MFDS website under the agency's legal information section.

Meanwhile, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have also been moving toward reducing unnecessary clinical burdens in biosimilar development by placing greater emphasis on analytical comparability, non-clinical data and pharmacokinetic assessments in the approval process.

The MFDS said the latest reform is in line with this global regulatory shift toward more efficient and science-based biosimilar evaluation.