South Korea · Ministry of Food and Drug Safety · Biosimilars
Review target
115 working days
regulation
Legal time limit
-
Not published
Steps
4
7 requirements
Application fee
₩310,000,000
From 2026-01-01
A biosimilar must show comparability with a biologic already licensed in Korea in quality, nonclinical and clinical terms. The rules call for a pharmacokinetic study and a confirmatory clinical trial, but the confirmatory trial can be skipped when quality, nonclinical and pharmacokinetic comparability is shown. A copy of a licensed biological product, such as a monoclonal antibody or recombinant protein.
The official review target is 115 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The item permit, biosimilar (electronic filing) is ₩310,000,000 for From 2026-01-01. A reduced fee of ₩155,000,000 applies in some cases (Small and medium firms pay 50 percent).
1. Submit the item permit application; 2. Review of comparability data (115 days); 3. Answer requests for more data; 4. Permit decision.
Outcome: An item permit valid for 5 years and renewable; each lot then needs national lot release where the product is subject to it. Valid for 5 years.
Legal basis: Pharmaceutical Affairs Act, Article 31; Regulation on Approval and Review of Biological Products, Articles 2(10), 23 and 24
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 115 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Official processing periods, not actual review times. Periods over 5 days count working days (Saturdays and public holidays are not counted). Time the applicant spends answering requests is outside the period. | 115 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Item permit, biosimilar (electronic filing)Application · From 2026-01-01 · Small and medium firms pay 50 percent. | ₩310,000,000reduced ₩155,000,000 |
Other routes in South Korea: Item permit for biological products and vaccines, National lot release for vaccines and other biologics, Priority review designation (GIFT), Conditional item permit, Orphan drug designation. See all routes on the South Korea page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.