The government is dramatically easing requirements for Phase 3 clinical trial and animal testing data submissions for biosimilars — also known as follow-on biologics — to strengthen the domestic industry's global competitiveness. The move aims to cut product development time and costs by removing excessive regulatory burdens while maintaining safety standards.
The Ministry of Food and Drug Safety announced Tuesday it would revise and implement its "Regulations on Product Approval and Review of Biological Products" to streamline clinical trial and nonclinical animal testing data submission requirements for biosimilars, in support of faster development and greater alignment with global regulatory standards.
The revision follows a biotech innovation forum held last September and chaired by the president. The ministry ran a public-private consultative body on biosimilar clinical improvement to gather industry input and finalize the proposal.
Under the revised rules, companies seeking approval for a biosimilar will no longer be required to submit Phase 3 trial data if they can clearly demonstrate comparative equivalence with the reference product in terms of quality, nonclinical findings and pharmacokinetics. Previously, both Phase 1 and Phase 3 trial results were mandatory for establishing comparative equivalence.
Nonclinical animal testing obligations will also be reduced. In line with the global regulatory trend toward minimizing animal testing, the ministry has harmonized its rules so that companies may forgo submitting repeated-dose toxicity test data — which involves administering a test substance to laboratory animals multiple times to assess toxicity — once comparative equivalence in quality and pharmacology has been established.
To prevent industry confusion from the regulatory changes, the ministry published a guidance document outlining the factors companies should consider when deciding whether to conduct a Phase 3 clinical trial for a biosimilar. The ministry has also established a pre-review system allowing companies to discuss with regulators in advance whether clinical trials are necessary; the system has been in operation since March.
"This revision improves development requirements within the bounds of safety assurance, reflecting global regulatory trends," a ministry official said. "We expect it to shorten product development timelines and reduce costs for domestic biosimilars, contributing to stronger global competitiveness. We will continue to pursue regulatory innovation grounded in scientific evidence and safety."
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