Spain, through the European Union route · European Medicines Agency · Biosimilars
Review target
210 days
regulation
Legal time limit
-
Not published
Steps
8
9 requirements
Application fee
€732,400
From 2025-01-01
A biosimilar is a biological medicine highly similar to a reference biological medicine already approved in the EU. The applicant shows similarity through comparability studies and adds the non-clinical and clinical data needed for the differences. The European Medicines Agency reviews it under the same 210-day opinion limit. Biological products similar to an EU reference biological medicine that do not meet the generic definition because of differences in raw materials or manufacturing.
The official review target is 210 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The centralised biosimilar marketing authorisation application under article 10(4) is €732,400 for From 2025-01-01.
1. Pre-submission and eligibility; 2. Initial assessment and list of questions (120 days); 3. First clock stop: applicant answers; 4. Further assessment and list of outstanding issues (60 days); 5. Second clock stop (if needed); 6. Committee opinion (30 days); 7. Re-examination (optional); 8. Commission decision (67 days).
Outcome: One marketing authorisation valid in every EU country, decided by the European Commission. Valid for 5 years.
Legal basis: Directive 2001/83/EC, Article 10(4); Regulation (EC) No 726/2004, Annex I
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 458 days end to end with the official step targets, of which up to 121 days are clock stops (time the applicant uses to answer). Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionofficial guidance. Time for the Commission decision after the agency recommendation, as stated by the agency. | 67 days |
| Review targetregulation. Maximum active days for the committee opinion. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 210 days |
| Typical total timeofficial guidance. The agency says the assessment of a new medicine usually lasts around a year, including clock stops. This is a general statement, not a target. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Centralised biosimilar marketing authorisation application under Article 10(4)Application · From 2025-01-01 · SMEs: payment deferred until the decision. | €732,400 |
| Annual fee per centrally authorised biosimilarYearly · From 2025-01-01 · SMEs: 40% reduction; micro enterprises: 100% reduction. | €118,100 |
Other routes in Spain: Centralised marketing authorisation, new active substance, Centralised marketing authorisation, known active substance or new fixed combination, Accelerated assessment, Conditional marketing authorisation, Authorisation under exceptional circumstances, PRIME (priority medicines), Orphan designation, Paediatric investigation plan, Integral drug-device combination authorised as a medicine. See all routes on the Spain 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 (28 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.