Switzerland · Swissmedic · Biosimilars
Review target
330 days
official guidance
Legal time limit
-
Not published
Steps
8
8 requirements
Application fee
CHF 50,000
2026
A biosimilar is a biological medicine that is sufficiently similar to a reference product authorized in Switzerland and refers to its documentation. Biotechnology products cannot use the simplified route, so a biosimilar needs full quality data and comprehensive comparability studies. If the European Commission or the US FDA has already authorized the same biosimilar, the agency can rely on that decision. Copies of biological medicines authorized in Switzerland.
The official review target is 330 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The new authorization of a known active substance not eligible for the simplified procedure (applies to biotechnology products such as biosimilars) is CHF 50,000 for 2026.
1. Submit the application; 2. Formal control and technical validation (30 days); 3. Applicant corrects formal gaps (clock stopped) (60 days); 4. Evaluation phase I (120 days); 5. Applicant answers the list of questions (clock stopped) (90 days); 6. Evaluation phase II and preliminary decision (90 days); 7. Applicant replies to the preliminary decision (clock stopped) (60 days); 8. Labeling review and official decision (90 days).
Yes. It relies on approvals from European Union, United States (shorter review, shorter review).
Outcome: Authorization for five years, renewable. Valid for 5 years.
Legal basis: Therapeutic Products Act (HMG) Article 4 para. 1 let. aocties and anovies; Therapeutic Products Ordinance (VAM) Article 17; Ordinance on Simplified Authorisation (VAZV) Article 12 para. 5 and 6
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 480 days end to end with the official step targets, of which up to 210 days are clock stops (time the applicant uses to answer). 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 targetofficial guidance. Official target for agency time only, counted in calendar days. Time the applicant takes to answer is not counted. Actual review times can differ. The maximum total, including applicant time, is 540 days. | 330 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New authorization of a known active substance not eligible for the simplified procedure (applies to biotechnology products such as biosimilars)Application · 2026 | CHF 50,000 |
Other routes in Switzerland: Ordinary authorization of a medicine with a new active substance, Authorization based on a foreign authorization (Article 13 procedure), Fast-track authorization procedure, Procedure with prior notification (20 percent shorter review for a double fee), Temporary authorization (incomplete data), Orphan drug status (important medicine for a rare disease), Temporary permit for use outside clinical trials or limited marketing, Pediatric investigation plan and pediatric incentives. See all routes on the Switzerland 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 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.