UK – Licensing of biological products: biosimilars, ATMPs and PMFs in a no-deal Brexit

This guidance sets out the procedures that the MHRA will introduce to regulate biological medicines in the event of no-deal Brexit.

If the UK leaves the EU without a deal, the MHRA will continue to regulate biosimilar products according to the same principles that are applicable now. These are covered in regulation 58 of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 amending Reg 53 of The Human Medicines Regulations 2012.

New applications will be assessed at national level and should be submitted using existing procedures for national applications.

Applications for biosimilar products will also be eligible for the targeted assessment procedure after a final opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has been obtained.

For biosimilar applications submitted after exit day, the application can only be made with reference to a product that complies with regulation 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.

These will include products that are authorised, or have been authorised for at least 8 years in the UK and those authorised by conversion from EUMarketing Authorisations (MA). It also includes products for which an EUmarketing authorisation was in force on exit day but which did not convert into UK marketing authorisations as the holder opted out of that process.

Data and market exclusivity period entitlements for reference medicinal products approved before the date of UK exit from the EU will continue to be applicable in the UK.

As part of the supporting data package, the UK will continue to accept data generated on reference product sourced in accordance with the ‘Guideline on similar biological medicinal products CHMP/437/04 Rev1’.

We have more information about biosimilar products on our website.