United Kingdom · Medicines and Healthcare products Regulatory Agency · Biosimilars
Review target
150 days
official guidance
Legal time limit
210 days
regulation
Steps
5
7 requirements
Application fee
-
A biosimilar shows that it is highly similar to a UK reference biological medicine. The MHRA handles it on the innovative medicines timetable. In most cases a comparative efficacy trial may not be needed when the science supports this. A biological medicine similar to an authorised UK reference biological medicine, where differences in raw materials or manufacturing mean it cannot be a generic.
The official review target is 150 days (official guidance). The legal time limit is 210 days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Submission on a monthly deadline; 2. Initial assessment to Day 90 (90 days); 3. Applicant answers questions; 4. Assessment of answers to Day 150 (60 days); 5. Decision.
Outcome: A UK-wide marketing authorisation, valid for five years at first. Valid for 5 years.
Legal basis: Human Medicines Regulations 2012, regulation 53B
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 333 days end to end with the official step targets, of which up to 183 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. Possible positive decision by Day 150. Official target in calendar days, not an actual review time. Time the applicant takes to answer questions does not count. | 150 days |
| Legal time limitregulation. Period suspended while requested information is awaited. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in United Kingdom: National assessment for innovative medicines, International Recognition Procedure, Recognition A, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway (ILAP), Rolling review, MHRA-NICE aligned pathway, Independent batch release for vaccines and blood products. See all routes on the United Kingdom page or explore them in the .
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.