The Korea Food and Drug Administration (KFDA) has relaxed requirements for submitting clinical trial data and certain animal testing materials during the development of biosimilars. This move aims to reduce the burden on domestic pharmaceutical and biotech companies and enhance their global competitiveness.
On July 14, the KFDA announced the implementation of revised regulations for the approval and review of biological products. Biosimilars are biological medicines that have demonstrated quality and non-clinical and clinical comparability to existing approved drugs.
According to the revisions, if quality, non-clinical, and pharmacokinetic comparability are established, the submission of clinical trial data from Phase 3 can be waived. Previously, both Phase 1 and Phase 3 clinical trial data were required for biosimilar approval.
The requirements for animal testing have also been eased. If quality and pharmacological comparability are confirmed, the submission of repeated-dose toxicity test data can be omitted. This change aligns with international regulatory trends aimed at reducing unnecessary animal testing.
This revision follows a bio-innovation strategy meeting chaired by the President in September of last year. The KFDA stated that it revised the regulations based on feedback from industry stakeholders through public-private consultations.
Earlier this year, the KFDA published guidelines on the criteria for determining the necessity of Phase 3 clinical trials for biosimilars and established a system for pre-reviewing clinical trial plans in the early stages of development.
The KFDA expressed optimism that the revisions will reduce development time and costs, thereby enhancing the global competitiveness of domestic companies. It also emphasized its commitment to ongoing regulatory innovation based on scientific evidence and safety.
Meanwhile, the growth of the biosimilar and contract development and manufacturing organization (CDMO) sectors has driven record production and exports of pharmaceuticals. According to KFDA data, pharmaceutical production reached 33.8466 trillion won last year, a 3.0% increase from the previous year. For the first time, domestic pharmaceutical exports surpassed $10 billion (approximately 15.5 trillion won), marking the highest production figures since related statistics began in 1998.
On July 14, the KFDA announced the implementation of revised regulations for the approval and review of biological products. Biosimilars are biological medicines that have demonstrated quality and non-clinical and clinical comparability to existing approved drugs.
According to the revisions, if quality, non-clinical, and pharmacokinetic comparability are established, the submission of clinical trial data from Phase 3 can be waived. Previously, both Phase 1 and Phase 3 clinical trial data were required for biosimilar approval.
The requirements for animal testing have also been eased. If quality and pharmacological comparability are confirmed, the submission of repeated-dose toxicity test data can be omitted. This change aligns with international regulatory trends aimed at reducing unnecessary animal testing.
This revision follows a bio-innovation strategy meeting chaired by the President in September of last year. The KFDA stated that it revised the regulations based on feedback from industry stakeholders through public-private consultations.
Earlier this year, the KFDA published guidelines on the criteria for determining the necessity of Phase 3 clinical trials for biosimilars and established a system for pre-reviewing clinical trial plans in the early stages of development.
The KFDA expressed optimism that the revisions will reduce development time and costs, thereby enhancing the global competitiveness of domestic companies. It also emphasized its commitment to ongoing regulatory innovation based on scientific evidence and safety.
Meanwhile, the growth of the biosimilar and contract development and manufacturing organization (CDMO) sectors has driven record production and exports of pharmaceuticals. According to KFDA data, pharmaceutical production reached 33.8466 trillion won last year, a 3.0% increase from the previous year. For the first time, domestic pharmaceutical exports surpassed $10 billion (approximately 15.5 trillion won), marking the highest production figures since related statistics began in 1998.
* This article has been translated by AI.
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