The Korea Biopharmaceutical Association welcomed a new guideline issued on Tuesday by the National Institute of Food and Drug Safety Evaluation, an arm of the Ministry of Food and Drug Safety, titled "Considerations for Deciding Whether to Conduct Comparative Efficacy Clinical Trials for Biosimilars (Applicant Guidance)."
The association said the guideline, released at a time of rapid growth in the domestic and global biosimilar market, represents a critical regulatory innovation that will decisively bolster export competitiveness by reducing development costs and timelines.
"The guideline establishes a flexible pathway that allows companies to determine whether to conduct Phase 3 clinical trials through a pre-review process when equivalence and safety have been sufficiently demonstrated through quality data and Phase 1 clinical results," an association official said. "The U.S. FDA's Revision 4 is also pursuing streamlining in the same direction, so this is in line with the international trend."
The official added, "This measure will serve as a catalyst that strengthens the entire 'K-Biosimilar' export ecosystem by accelerating global market entry not only for leading companies such as Celltrion (068270.KS) and Samsung Bioepis but also for emerging players."
According to the association, 90% — approximately 106 — of biologic drugs with patents expiring in the United States between 2025 and 2034 currently have no biosimilar pipeline, representing a market opportunity worth approximately $232 billion (349.856 trillion won). In Europe, 79% of roughly 100 biologic drugs whose exclusivity rights expire by 2032 have no biosimilars currently in development. The potential lost opportunity is estimated at approximately $1.043 trillion (215.644 trillion won).
"This means that if domestic companies expand their pipelines, a vast blue ocean awaits in both the U.S. and European markets," the official said.
South Korea was named the country with the most FDA biosimilar approvals for two consecutive years in 2024 and 2025. Export volume surged 50% from approximately $980 million (1.4778 trillion won) in 2021 to approximately $1.47 billion (2.2165 trillion won) in 2022, sustaining steep growth momentum.
"At a time when the biosimilar market is growing explosively, this Phase 3 relaxation guideline is tantamount to handing domestic companies a 'weapon of timing' to seize the global market," Lee Jeong-seok, chairman of the Korea Biopharmaceutical Association, said. "The association will provide full support so that member companies can maximize this opportunity and strengthen K-Biosimilar dominance in the world market."
Lee added, "The association will continue to offer briefings and hands-on support for pre-review procedures to member companies, and will actively participate in the process of revising related approval regulations."