In an interview with the Center for Biosimilars®, Maria Manley, LLM, London-based partner of Sidley Austin, explored the complex challenges that Brexit, which marked the UK’s official exit from the European Union, presented regulators and the biopharmaceutical industry. .
In preparation, pharmaceutical companies had to ensure that they were properly registered and domiciled in order to be able to continue doing business in the UK and Europe.
The United Kingdom and the European Union have entered into a free trade agreement without tariffs or quotas. However, border controls and product movement are problematic in Northern Ireland, which is part of the UK but is still allowed to follow certain EU rules. Manley said two types of litigation apply to those jurisdictions, adding to the complexity of Brexit.
On the positive side, the UK has agreed to temporarily recognize the marketing authorizations for pharmaceutical drugs previously approved in the European Union, thus ensuring that any impact on the drug supply is minimal.
Some of the regulatory changes for the biologics industry include the end of animal toxicology studies. In addition, comparative efficacy studies will only be necessary if the UK Medicines and Health Products Regulatory Agency considers that there is sufficient reason.
A new approval path for biologics has been designed with the aim of simplifying the current system and speeding up the process of bringing innovative medicines to market. Manley said the UK may be willing to accept real-world evidence to support product approval applications.
In addition, Manley discussed the ‘continuous review’ feature added to the UK drug approval process, which was created to allow applications to move quickly to regulatory review. This review format will apply to new biologics, including biosimilars.