South Korean regulators have revised requirements to significantly reduce the time and financial burden of biosimilar development. The policy changes are designed to ease the requirement for submitting Phase 3 clinical data, provided that quality, nonclinical, and pharmacokinetic comparability with the original reference drug has been sufficiently established.
The Ministry of Food and Drug Safety (MFDS) announced on July 14 that it will revise and implement the “Regulations on Product Approval and Review for Biological Products, etc.” The initiative is aimed at accelerating biosimilar development and harmonizing South Korea's standards with global regulatory frameworks.
The core of the revision focuses on streamlining the documentation required for Phase 3 clinical trials and animal testing during the biosimilar approval process. Previously, developers were required to submit clinical data from both Phase 1 and Phase 3 trials to prove therapeutic equivalence to the originator drug.
Reducing the Burden of Phase 3 Trials and Animal Testing
Under the newly revised rules, companies can bypass Phase 3 clinical trial submissions if they can successfully prove comparability across quality, nonclinical, and pharmacokinetic metrics. Pharmacokinetics—which measures how a drug is absorbed, distributed, metabolized, and excreted in the body—is utilized in biosimilar development to confirm that drug exposure levels in the human body are sufficiently similar to those of the originator product. The MFDS emphasized that the shift is intended to eliminate redundant, duplicative clinical submissions without compromising patient safety.
Additionally, the standards for animal studies have been updated. If a biosimilar's quality and pharmacological comparability are established, developers may be permitted to waive the submission of repeated-dose toxicity test data. This test evaluates potential toxicity by repeatedly administering a substance to animal models. Easing this requirement aligns South Korean regulations with the international regulatory trend of minimizing animal testing.
Pre-Consultation and Global Alignment
The revision follows the "Bio Innovation Discussion Forum" chaired by the president in September of last year. In preparation for the notice, the MFDS operated a joint public-private consultative body to focus on improving biosimilar clinical trials and actively gathered feedback from industry stakeholders.
To support the transition, the agency has also established a pre-discussion framework. The MFDS published detailed guidance outlining the specific criteria considered when deciding whether to waive Phase 3 clinical trials. Furthermore, the agency has been operating a pre-review program since March of this year, allowing developers to consult with regulators in advance regarding their clinical trial designs.
"We have optimized the data submission requirements for biosimilar development within the strict boundaries of ensuring safety," an MFDS official said. "These changes will help developers reduce both time and costs, ultimately strengthening the international competitiveness of our bio-industry."
