Biological products in the post-Brexit world

The licensing of biological products (including biosimilars, advanced therapy medicinal products and plasma master files and vaccine antigen master files) from 1 January 2020 is covered by the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. The UK government guidance in relation to biological products is provided in the Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021 (1 September 2020).

Biosimilars (similar biological products)

Biosimilar products in Great Britain will be regulated by the MHRA according to the same principles that were applicable pre-1 January 2021. Biosimilar products in Northern Ireland will follow the EU acquis and the MHRA will regulate applications from 1 January 2021 onwards.

Applications for biosimilar products made after 1 January 2021 must be made with reference to a product that is a reference medicinal product under regulation 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, which is discussed further in our previous article Marketing Authorisations in the post-Brexit world.

Advanced therapy medicinal products (ATMPs)

After 1 January 2021, ATMPs will be regulated by the MHRA in Great Britain according to the same principles that applied pre-1 January 2021. Northern Ireland ATMPs will continue to be regulated under the EMA’s Centrally Authorised Procedure.

Data, traceability, exceptions from licensing, packaging and post-authorisation requirements that applied in the EU will be transposed into UK law. There will be no changes to the definitions of individual classes of ATMPs, which will continue to be classified as gene therapy medicinal products, somatic cell therapy medicinal products or tissue engineered products.

Plasma Master Files (PMFs) and Vaccine Antigen Master Files (VAMFs)

After 1 January 2021, the MHRA will continue to recognise existing PMFs until further notice. Further guidance will be provided by the MHRA in relation to the future transfer of the supervision of PMFs into a national system. Similarly, until further guidance is provided regarding the future transfer of PMFs to the MHRA database, the data requirements for PMFs will be according to what is currently in place for the EU.

The current guidance from the UK government is that the PMF holder should notify the MHRA of the outcome of annual updates within 4 weeks of the completion date. Similarly, the MHRA should be notified of the submission of variation applications within 4 weeks, and the determination outcome of such variation applications also within 4 weeks.

Applicants wishing to submit a VAMF should contact the MHRA for further guidance.

Batches

The National Institute for Biological Standards and Control (NIBSC) has provided guidance in relation to the certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products.

From 1 January 2021, EU Directive 2001/83/EC (Article 114) will no longer apply in Great Britain. Instead, NIBSC will be a stand-alone National Control Laboratory. The NIBSC will independently certify batches of biological medicines that are to be used exclusively in Great Britain.

Batches that have an EU Official Control Authority Batch Release (OCABR) certificate issued on or before the end of the transition period will be accepted by Great Britain. After 1 January 2021, samples and documentation relating to batches for use in Great Britain will need to be sent to the NIBSC. NIBSC certification is not required for batches that were manufactured and certified by a country with whom the UK has a mutual recognition agreement (the initial expectation is that these countries will be Switzerland and Israel), though re-examination of the batches by NIBSC is permitted where there are public health concerns. Further information on the procedure for batches that fall under a mutual recognition agreement will be published in the future.

For batch release in the EU, NIBSC continues to offer batch release testing via subcontracting arrangements with a European Official Medicines Control Laboratory. For non-EU/EEA/UK countries, the NIBSC will continue to certify batch releases.

For batch release in Northern Ireland, OCABR certificates will continue to be accepted, without further testing, and a NIBSC certificate will not be required. Where there is no OCABR certificate, the procedure for obtaining a NIBSC certificate in Northern Ireland is the same as the procedure for Great Britain.

Applicants are encouraged to contact the NIBSC to discuss the specific arrangements for their products.

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