Japan · Pharmaceuticals and Medical Devices Agency · Biosimilars
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
10 requirements
Application fee
-
A biosimilar is a biotechnology medicine developed by a different company to have quality, safety and efficacy equivalent to an approved original biologic. Approval rests on comparison data. A clinical trial on efficacy is needed when quality and PK or PD data are not enough to conclude equivalence. A recombinant protein, peptide or related medicine that is equivalent to a biotechnology medicine already approved in Japan as a new active ingredient.
1. File the application through PMDA; 2. Scientific review and compliance survey; 3. Approval by the health minister.
Outcome: Product approval from the health minister.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 14
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Japan: Approval held by a foreign manufacturer through a designated marketing authorization holder. See all routes on the Japan 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.