Maria Manley, LLM, a life sciences expert and London-based partner with Sidley Austin, provides a deep-dive look at the complexities of Brexit and how it is likely to challenge the biologics industry.
In an interview with The Center for Biosimilars®, Maria Manley, LLM, a London-based partner with Sidley Austin, explored the complex challenges that Brexit, which marked the United Kingdom’s official exit from the European Union, has presented regulators and the biopharmaceutical industry.
In preparation, pharmaceutical companies have had to ensure that they were properly registered and domiciled so that they could continue doing business in the United Kingdom and Europe.
The United Kingdom and the European Union established a free trade agreement without tariffs and quotas. However, border checks and product movement present problems in Northern Ireland, which is a part of the United Kingdom but is still allowed to follow some EU rules. Manley said there are 2 sets of litigation applying to these jurisdictions, which add to the complexities of Brexit.
On the upside, the United Kingdom has agreed to acknowledge temporarily the marketing authorizations for pharmaceutical drugs that were previously approved in the European Union, ensuring that any impacts on drug supply are minimal.
Some of the regulatory changes for the biologics industry includes an end to animal toxicology studies. Further, comparative efficacy studies will be required only if the United Kingdom’s Medicines and Health products Regulatory Agency deems that there is a sufficient reason.
A new approval pathway for biologics was designed with the intention of simplifying the current system and accelerating the process to get innovative medicines on the market. Manley said that the United Kingdom may be willing to accept real world evidence in support of product approval applications.
Additionally, Manley discussed the “rolling review” feature added to the United Kingdom’s medicines approval process, which was created to enable applications to move through regulatory review quickly. This review format will apply to novel biologics, including biosimilars.