If you’re looking to bring a biologic or biosimilar to the UK market, then the first thing you need is a Marketing Authorisation from the MHRA. That means putting together a full CTD dossier, proving your manufacturing is GMP-compliant, having a Risk Management Plan ready and ensuring all regulatory documentation is complete and submission-ready.
And as of 1 January 2025, under the Windsor Framework implementation, it’s a single licence for the entire UK, covering Great Britain and Northern Ireland together. An EU or EMA approval doesn’t count on its own anymore. That’s the shape of Biologics and Biosimilars Registration in the UK today.
This guide walks through who actually oversees your product, what documents you’ll need, roughly how long approval takes and what’s expected of you once the licence lands in your hands.
Regulatory Authority for Biologics and Biosimilars in UK
Anyone bringing a biologic or biosimilar to the UK market will primarily deal with the Medicines and Healthcare products Regulatory Agency. MHRA acts as the UK Biologics Regulatory Authority, and MHRA Biologics Approval and MHRA Biosimilars Regulation both fall under this agency. It assesses applications, issues Marketing Authorisations, inspects manufacturing sites and runs pharmacovigilance oversight for the whole of the UK.
But it doesn’t work alone and applicants often get confused about where one body’s job ends and another’s begins. The following table explains the roles of the different regulatory authorities.
| Authority | Core Function |
| MHRA (Medicines and Healthcare products Regulatory Agency) |
Marketing authorisation, inspections, pharmacovigilance
|
| DHSC (Department of Health and Social Care) |
Health policy oversight
|
| CHM (Commission on Human Medicines) |
Scientific advisory input
|
| HRA (Health Research Authority) |
Clinical trial ethics and research governance
|
| NICE (National Institute for Health and Care Excellence) |
Health technology assessment, reimbursement
|
UK Biologics and Biosimilars Regulatory Requirements
Biologics Regulatory Requirements UK and Biosimilars Regulatory Requirements UK both trace back to the same core legislation, the Human Medicines Regulations 2012. It is the primary legal base that controls licensing, labelling, pharmacovigilance and manufacturing obligations for human medicines in the UK. And what gave the UK the legislative flexibility to make these regulations on its own, after leaving the EU system, was the Medicines and Medical Devices Act 2021.
Biosimilar applications specifically have to comply with Regulation 53B of the Human Medicines Regulations 2012.
Reference biologics get 10 years of protection before a biosimilar can lean on their data. The first 8 years are data exclusivity, biosimilar applicants simply can’t reference the innovator’s data during this window, full stop. After that comes 2 years of market exclusivity, where a biosimilar can actually get approved, but it still can’t be sold. That gap matters for planning, as regulatory approval and commercial launch are not the same milestone.
A few other regulatory requirements are:
- UK Good Manufacturing Practice (GMP) or an equivalent recognised standard.
- Good Distribution Practice (GDP)
- A UK Qualified Person for Pharmacovigilance (QPPV) and a Pharmacovigilance System Master File are mandatory.
- Great Britain doesn’t currently require FMD-style serialisation, since the UK left that EU scheme, but Northern Ireland’s rules differ and have changed before, so check current MHRA guidance for your product.
MHRA also continues to use ICH quality, safety and efficacy guidelines as important scientific references. For biologics, the ICH Q5 series remains particularly relevant when preparing manufacturing and quality sections of the regulatory dossier. ICH guidelines adopted by MHRA- quality (Q-series), safety and efficacy guidelines remain central reference points for dossier preparation, including ICH Q5 for biotechnological products.
Build your GMP and pharmacovigilance infrastructure in parallel with dossier preparation. MHRA validation checks for these early and gaps here are one of the most common causes of delay.
Biologics and Biosimilars Registration Process in UK
The Biologics Approval Process in the UK and the Biosimilars Approval Process in the UK follow the same numbered sequence. The only real difference comes at the scientific assessment stage.
Understanding why each stage matters saves applicants a lot of back-and-forth.
Step 1: Application submission
The applicant files a UK Marketing Authorisation for Biologics through the MHRA Submissions Portal using eCTD format.
Step 2: Validation
MHRA checks the dossier is complete and correctly structured before scientific review begins. Incomplete Module 3 (quality) data is a frequent cause of validation failure for biologics specifically, because of the volume of analytical and manufacturing information required.
Step 3: Scientific assessment
Assessors review quality, non-clinical and clinical data. For biosimilars, this centres heavily on the comparability exercise against the reference product rather than standalone efficacy data.
Step 4: CHM advice
For complex or novel biologics, MHRA may seek Commission on Human Medicines input before reaching a decision.
Step 5: Benefit-risk evaluation
MHRA weighs the demonstrated benefits against identified risks, informed by the Risk Management Plan and safety data submitted.
Step 6: MHRA decision
The application is either granted or sent back with questions requiring applicant response. When further information is required, a clock stop is initiated. The review timeline pauses while MHRA waits for the applicant’s answers, then resumes once a complete response is submitted.
Step 7: Grant of UK Marketing Authorisation
Once granted, the product receives a PL number valid across the UK.
Step 8: National implementation
The marketing authorisation holder must then ensure the product information, packaging and pharmacovigilance systems are operational before launch.
International Recognition Procedure (IRP)
It has been around since 1 January 2024 and it’s worth knowing about. It lets applicants lean on an approval they’ve already secured from a trusted regulator elsewhere, including the EMA, US FDA, Health Canada, Australia’s TGA, Swissmedic, Japan and Singapore.
There are two tracks to choose from. Recognition A runs on a 60-day timeline and suits the more straightforward applications. Recognition B takes 110 days and comes into play when the application needs a closer look. Either way, you still have to meet the UK’s own regulatory requirements, that part doesn’t go away, but IRP can get you to a decision noticeably faster than going through the standard national route.
Documents Required for Biologics and Biosimilars Registration
Biological Medicinal Products Registration UK submissions use the Electronic Common Technical Document (eCTD) format, structured across five modules:
- Module 1: administrative information, SmPC, PIL, labelling, UK-specific forms
- Module 2: summaries and overviews of quality, non-clinical, and clinical data
- Module 3: quality documentation, including manufacturing process, characterisation and control strategy
- Module 4: non-clinical study reports
- Module 5: clinical study reports, and for biosimilars, the comparability data package
A few more things belong in the submission are:
- Risk Management Plan (RMP)
- Pharmacovigilance System Master File (PSMF)
- GMP certificates for all manufacturing sites involved
- Manufacturing site information, including any third-party or contract manufacturers
Clinical Trial Requirements for Biologics and Biosimilars
UK Biologics Clinical Trial Requirements and UK Biosimilars Clinical Trial Requirements aren’t the same. Biosimilars usually don’t need a full standalone efficacy programme.
Regardless of the product type, clinical trials conducted in the UK require:
- MHRA Clinical Trial Authorisation (CTA), required before a trial can start
- HRA and Research Ethics Committee approval, run alongside the CTA application
- Compliance with Good Clinical Practice (GCP)
For new biologics, this usually involves the conventional Phase I-III clinical trial programme. But Biosimilars work differently. Since they’re built on a product that’s already proven itself, MHRA doesn’t expect that same ground to be covered again. Instead, its guidance on licensing biosimilar products focuses the clinical work on proving the biosimilar matches the reference product, mainly through:
- Comparability studies against the reference product across quality, non-clinical, and clinical parameters
- PK/PD studies to demonstrate similarity in how the product behaves in the body
- Immunogenicity assessment, given the risk of immune response differs by product class
- Clinical efficacy studies, only where scientific justification shows analytical and PK/PD data alone can’t establish biosimilarity
MHRA has said confirmatory efficacy trials aren’t always needed for biosimilars, as long as the analytical, functional and PK/PD data are strong enough on their own. That’s a real difference from a novel biologic application, so it’s worth checking with MHRA through scientific advice early rather than assuming it applies to you.
Labelling Requirements for Biologics and Biosimilars
Biologics Labelling Requirements UK apply through the Human Medicines Regulations 2012 and cover the SmPC, PIL, and outer packaging together as one connected package of product information.
Key requirements:
- Summary of Product Characteristics (SmPC): must use the current MHRA SPC template exactly as issued. Unaltered templates are required or the submission is rejected
- Patient Information Leaflet (PIL): derived from the SmPC, written for patient comprehension
- Outer packaging: must reflect the approved product information consistently
- English language requirement: product information must be in English for the UK market (Welsh language requirements apply in Wales separately)
- UK serialisation: Great Britain currently sits outside the EU FMD scheme. Specific pack requirements should be confirmed against current MHRA guidance for the product type
Timeline for Biologics and Biosimilars Approval
MHRA’s National Assessment Procedure, effective for applications received from 3 April 2025, sets out two published timetables measured in calendar days, excluding clock-stops:
- Up to 210 days for the standard track covering new active substances, ATMPs, vaccines, biosimilars, and other innovative or established medicines
- Up to 150 days for an accelerated track, available on request, where one round of questions is enough to resolve outstanding issues
On the standard track, MHRA sends its first round of questions (an RFI) by Day 90. That pauses the clock until you respond, then it starts again. If CHM input is needed, that adds extra time. Since exact timelines depend on the application type, always confirm the precise schedule with MHRA before planning your launch date.
MHRA also runs two work-sharing initiatives, NASWSI for new active substances and BSWSI for biosimilars, which allow joint assessment with other international regulators on a separate schedule, where eligible.
Fees for Biologics and Biosimilars Registration
MHRA fees are set out in statutory fee regulations and get updated periodically. They vary by application category, new active substance, biosimilar, line extension, provisional authorisation and so on, so there’s no single number that applies across the board.
Check MHRA’s current published fee schedule directly for the exact figure that applies to your application type before budgeting.
PMS and Pharmacovigilance Requirements
Biologics Post Marketing Surveillance UK obligations don’t end at licence grant. In fact, they last for as long as the product remains on the market.
PMS and pharmacovigilance requirements include:
- Periodic Safety Update Reports (PSURs): submitted on a schedule set at authorisation and reviewed by MHRA
- Risk Management Plan (RMP): updated as new safety information emerges, not filed once and forgotten
- Signal detection: ongoing monitoring for new or changing safety signals, particularly relevant for biologics given immunogenicity risk
- Adverse event reporting: the Marketing Authorisation Holder must report adverse events to MHRA within defined timeframes
- Manufacturing variations: any change to the manufacturing process for a biologic typically requires a variation application, given how sensitive biological products are to process changes
- MHRA inspections: covering GMP, GDP, and pharmacovigilance systems on a risk-based schedule
- Batch traceability: biologics require batch-level traceability given the nature of biological manufacturing and the theoretical risk of batch-to-batch variability
- Product quality complaints and defect reporting: must feed into a formal complaint-handling system, with recalls initiated where MHRA determines a quality or safety risk
Conclusion
Getting a biologic or biosimilar licensed in the UK isn’t fundamentally different in structure from other medicines. It’s the depth of quality data, the comparability requirements for biosimilars and the ongoing pharmacovigilance burden that set it apart. Manufacturers who plan GMP readiness, documentation consistency and clinical strategy together, rather than as separate workstreams, tend to move through MHRA review with fewer delays.
We’ve helped manufacturers get biologics and biosimilars through UK registration, start to finish. If that’s where you’re headed next, Artixio is a call away. Reach out to us at info@artixio.com
FAQs
Q1. Is a separate UK Marketing Authorisation required if a biologic is already approved by the EMA?
Yes. An EMA approval doesn’t carry over to Great Britain automatically. You still need a separate MHRA application, though EMA data can support it.
Q2. Do biosimilars always need full clinical efficacy trials in the UK?
Not always. If the analytical, functional, and PK/PD data are strong enough, MHRA may not require a separate efficacy trial. It’s decided case by case.
Q3. What’s the difference between MHRA and National Institute for Health and Care Excellence (NICE) in the biologics approval process?
MHRA grants the licence to sell the product. NICE decides whether the NHS will fund it. A product can be licensed and still waiting on NICE.
Q4. How does Northern Ireland’s regulatory position differ from Great Britain’s for biologics?
As of 1 January 2025, it doesn’t. One MHRA licence now covers both. Before that, NI needed a separate EU authorisation alongside the GB one.
Q5. What causes the most delays in UK biosimilar registration?
Mainly incomplete Module 3 data, mismatched SmPC/PIL/packaging text, and comparability studies run on the wrong reference product batches.
Q6. Are biosimilars interchangeable with their reference product in the UK, and can a pharmacist substitute one for the other?
Yes, they’re interchangeable, a prescriber can switch between them. But pharmacists can’t substitute one for the other without the prescriber’s sign-off.
Q7. Is there a faster route to a UK licence for a biologic already approved in the EU or US?
Yes, the IRP. It lets MHRA rely on an existing approval from a trusted regulator, cutting review time to 60-110 days instead of the standard 150-210.
