Divya Chadha Manek, head of business development at the National Institute for Health Research (NIHR)

Companies should bring their biosimilar studies to the UK. Here's why


Divya Chadha Manek, Head of Business Development, NIHR

Date: 03 September 2018

Cheaper NHS drugs are 'as safe and effective' ran the headline; in doing so busting the myth that cut-price always equals sub-standard. But we know this already at the National Institute for Health Research (NIHR). What we also know is that clinical research will play a crucial role in the biosimilars boom.

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 revolutionized 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, recently 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. And it’s incumbent on companies to prove that’s the case. Key to this then are clinical studies, including real-world evidence studies. And what better place to do this than within the NHS in the UK.

In the past decade, the NIHR has been at the forefront of clinical research in the UK. It has increased the volume of applied health research for the benefit of patients and the public, and accelerated the translation of scientific discoveries into tangible benefits for patients and the economy. We continue to support the life sciences industry to plan, set up and deliver high quality research to time and target in the NHS in England.

Yet back in 2016 global life science companies were overlooking 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’.

In response, the NIHR did a scoping exercise of clinical interest within conditions relevant to biosimilar medicines, such as cancer, gastroenterology, diabetes, dermatology, rheumatology and ophthalmology. Through the NIHR’s 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 wishing to cast their clinical investigator net beyond their usual little black book of contacts. As well as this, the NIHR has just launched a new online training course to raise awareness of biosimilar medicines and their potential benefits to the NHS.

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.”

Moreover, Pfizer’s Director of Clinical Site Management (UK and Ireland) Nikki Dewick has spoken of the “huge amount of support” the NIHR has given the Pharma giant when it comes to clinical trials, putting the increase in the studies being performed at Pfizer within the UK “down practically entirely to utilising the services of the NIHR".

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.

The UK’s offer to life science companies is clear. The NHS, together with the NIHR, makes the UK the ‘go-to’ destination for biosimilars studies.

Divya Chadha Manek's blog was originally published in PharmaTimes

The views and opinions expressed in this blog are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health and Social Care.
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