Not So Different: Has Brexit Hindered Biosimilar Development?

Maria Manley, LLM, a life sciences expert, talks about how the United Kingdom’s exit from the European Union has changed the regulatory landscape for biologics.

At the beginning of 2021, the United Kingdom officially parted ways with the European Union in the landmark event known as Brexit. Under Brexit, regulatory reforms have created challenges for pharmaceutical companies, including biosimilar developers, forcing them to restructure their activities to fit the needs of the British government’s policies and ensure that their products could still be marketed in the United Kingdom and across the European Union. The new regulatory independence in the United Kingdom has also created opportunities for innovation and growth.

We spoke with Maria Manley, LLM, a London-based partner with Sidley Austin and an expert on the life sciences, about the pros and cons of Brexit for the UK’s biologics industry.

To learn more about Brexit's impact on the biologics industry, click here.