With the patent protection for a number of leading biologic drugs set to expire in the coming years, the race is on within the life sciences industry to develop lower cost alternatives, known as biosimilars. Biologic medicines have revolutionised the treatment of many serious and chronic illnesses in the NHS, ranging from cancer through to rheumatoid arthritis and inflammatory bowel disease. Yet they are costly to develop and manufacture, which means they are expensive for the NHS to prescribe to patients.
Biosimilars, on the other hand, have the potential to drive huge cost savings while broadening patient access to cutting edge treatments. Indeed, just last month NHS Improvement announced that the NHS had saved £324 million in a year by switching to better value medicines.
It’s clear the buzz around biosimilars is getting louder, not least because of their rapid uptake and acceptance across the NHS in recent years. But there is still plenty to do to realise the full cost saving benefits of biosimilar medicines throughout the NHS. And much of this boils down to clinical confidence.
Patients and clinicians alike need to feel confident that they will experience the same benefit from a biosimilar medication as from an original biologic drug. It’s incumbent on companies then to prove that’s the case. Key to this is clinical research. 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 UK.
Yet back in 2016 global life science companies often overlooked the UK as a destination for biosimilar trials. They were struggling to generate enough interest from clinicians in the UK, citing that clinicians preferred to work with novel drugs or more frankly ‘sexy science’. Since then the UK has clearly stepped up its support for biosimilars.
NHS England continues to do an excellent job of championing the cause by bringing together key players in the biosimilar field: life sciences industry, patient groups, health professionals and NICE. A significant step-change came with the launch of NHS England’s Commissioning Framework for Biological Medicines (Including Biosimilar Medicines) in 2017.
Moreover, at the National Institute for Health Research, we did a scoping exercise of clinical interest within conditions relevant to biosimilar medicines, such as cancer, gastroenterology, diabetes and dermatology. Through our Clinical Research Network we asked all research-active clinicians across the entire NHS in England for a show of hands if they were interested in delivering trials of biosimilar drugs. That list currently runs at over 800 clinicians and continues to grow. It is a valuable tool for companies.
The UK is a unique place to deliver clinical research and is championed by clinicians and industry alike. NHS Rheumatologist and clinical investigator, Sonya Abraham talks of the NHS as “a great landscape to undertake clinical trials, and in particular biologics and biosimilars” while Professor Chris Griffiths, NHS Dermatologist and clinical investigator highlights the regional teams in dermatology who can “identify patients and run clinical trials in biologics and biosimilars to a very high standard” and how, importantly for industry, the UK has “demonstrated it can recruit to time and target”.
For companies keen to enter the biosimilars race, the UK is very much the ‘go-to’ destination.
Divya Chadha Manek is head of business development at the National Institute for Health Research