United Kingdom Hopes to Lure Biosimilar Developers for Clinical Trials

On the heels of revelations that the United Kingdom will not participate in the European Union’s new Clinical Trial Regulation (CTR) after Brexit, the National Institute for Health Research (NIHR) is attempting to keep biosimilar developers interested in conducting trials in the United Kingdom.

Divya Chadha Manek, head of business development for NIHR, wrote in an editorial at PharmaTimes that there is no better place to conduct a clinical trial of a biosimilar than the National Health Service (NHS). “Clinical studies, including real-world evidence studies, will continue to play a crucial role in the biosimilars boom. And what better place to run them than within the NHS in the [United Kingdom,]” wrote Manek.

Click to read more about biosimilars and the NHS.

According to Manek, the NIHR’s Clinical Research Network maintains an active list of more than 800 clinicians—practicing in oncology, gastroenterology, endocrinology, and dermatology—who are interested in delivering trials of biosimilar medicines.

Furthermore, the NIHR has launched an online resource, “Focus on Biosimilars,” that offers information for biosimilar developers on running a clinical trial in the NHS. The website includes resources related to the NIHR Study Support Service, a free service to the industry that offers a “flexible package of support” to help with site identification, delivery optimization, study setup, and performance monitoring.

It remains to be seen whether biosimilar makers will find NIHR’s offers tempting enough to compensate for the fact that the United Kingdom will become a more complex regulatory environment post-Brexit. Because the United Kingdom will not be eligible to participate in the upcoming CTR once it is no longer an EU member state, any developer seeking to conduct a clinical trial with sites in the European Union and the United Kingdom will have to apply separately to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency for approval. Furthermore, researchers in the United Kingdom will not have access to the EMA’s online portal and database that will form the single point for submitting and accessing trial information throughout the European Union.

Meanwhile, the EMA continues to feel the strain of Brexit; the European Parliament’s Committee on the Environment, Public Health, and Food Safety has issued an opinion to the Committee on Budgets that says that, due to the EMA’s increased workload resulting from Brexit-related activities, the agency requires additional resources. The committee has asked Parliament to add funds and staff for a limited period so that the EMA can “retain the critical knowledge and skills necessary to continue to carry out its tasks effectively and to resume currently postponed activities.”