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07.02.18

Buzzing about biosimilars

Source: NHE Jan/Feb 18

Biosimilars have the exciting potential to accelerate treatment access and drive huge cost savings across the NHS, explains Divya Chadha Manek, head of business development (commercial) at the National Institute for Health Research (NIHR).

‘Cost-saving’ or ‘cost-effective’ are terms that heighten the sense of interest within NHS management. Biosimilars, the next big thing to hit the NHS shelves, offer just that. They provide cost-effective treatments to patients within the NHS, helping the payer as well as the patient by increasing access to treatments, which perhaps in the past would not have been possible due to high costs of these treatments. However, it is time to take a step back. Biosimilars? Cost-effective? Increased access? What is this buzz around biosimilars all about? Let’s take a closer look at this new wave of drugs and what the future holds for us in the NHS.

A biosimilar is a biological medicine which is similar to another biological medicine already licensed for use. ‘Biological?’, you ask. Well, biological treatments have dramatically changed patient care by offering new and effective medicines for acute and chronic conditions. Biologics, as their name suggests, are harvested directly from biology. They are complex, large molecules and, in many cases, their exact composition is unknown. Due to their nature, they are happiest in a fluid form.

Biologics differ vastly from conventional drugs. Conventional medicines are essentially synthesised chemically and stitched together using chemical building blocks. The structure of a conventional medicine is well defined. Which is why when the patent for a conventional drug expires (i.e. the exclusive timeline for the company that develops a new treatment), it’s easy for other companies to make ‘copycat’ or ‘generic’ versions of those medicines as the composition is fully known. Generics are 100% identical to the original chemical drug. So, if you think of it this way, aspirin came on the market, went off patent, then many companies developed generics and now you and I can buy Tesco value aspirin for 16p.

What about biologics and biosimilars? These aren’t as simple as the example above. What happens is, biologic X comes onto the market, goes off patent and companies then aim to develop similar biological medicines – resulting in a biosimilar. Why is it a biosimilar and not called a generic or a copycat? That is due to the nature of biological medicines. Biological manufacturing process is different to chemical synthesis. The product cannot be 100% the same as it is when producing generics. Hence the name, biosimilars.

The largest NHS spend on a single drug in 2015-16 was a biologic, Adalimumab (over £416m). The patent for Adalimumab expires in October 2018. No surprise, then, that there are more than 15-20 companies preparing to enter the market with an Adalimumab biosimilar.

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The biosimilars buzz is here for multiple reasons. The first one being the promise of a smaller price tag. Biosimilars are cheaper than original biological treatments because the development costs for biosimilars are less. Why? Because for a new biological medicine, the company has to demonstrate that the product is safe and effective for one or more disease indications through an extensive programme of clinical trials. This is an expensive process.

For a biosimilar medicine, rather than conducting an extensive programme of clinical trials, the company has to demonstrate that the biosimilar is highly similar to the original reference product and that there are no clinically meaningful differences between the products. Therefore, biosimilar development timelines are shorter and less costly. Part of these savings can be passed onto the purchaser (i.e. the NHS), thus making biosimilars cheaper than the originators.

A great example of how biosimilars have driven costs down in healthcare systems can be seen in Norway. The use of the infliximab biosimilar instead of the originator reference Remicade has seen a staggering 69% cost reduction. The biosimilar now has 80% market share in Norway, providing staggering cost savings to the healthcare system.

The good thing about saving money is that you get to spend it somewhere else. The cost savings gained from switching to biosimilars can be channelled into enhancing patient care.

A model widely talked about in the UK is the Southampton model of biosimilars. The inflammatory bowel disease (IBD) clinic within University Hospital Southampton NHS FT agreed a “gain share” model with the local CCGs. A managed switching programme took place where patients established on Remicade were switched to the infliximab biosimilar. This was done in consultation with the patients and the clinical community. The cost savings were split between the parties, but more importantly, the savings were invested back into the clinical services, creating a win/win situation – what’s not to like about that?

I also mentioned increasing access, and you may wonder how this is possible. Since these biological medicines are expensive, normally there are strict thresholds and criteria which patients have to meet to be able to access these products.

If the budget for buying medicines remains the same, and we make cost savings, surely there is a case for two things to happen: 1) provide earlier access to these treatments for patients, and 2) lower the access threshold and treat a larger number of patients who, due to cost pressures, did not have access to these medicines previously.

Ready for it

With all of the above in mind, the NIHR has launched a campaign focusing on biosimilars. The NIHR aims to improve the health and wealth of nation through research. We are campaigning globally to promote NHS research and bring more biosimilar clinical trials into the UK.

Why? Because taking part in a biosimilar clinical trial before the product has been launched provides clinicians and patients with a forum to see how it works before it hits our shelves. A bit like ‘try before you buy.’ We conducted a scoping exercise of the clinical community in England and found that we have more than 620 clinicians across the NHS who are ready to deliver biosimilar clinical trials. This is a great start, but we now need to work towards everyone being willing to participate in biosimilars research in the NHS.

So, is this buzz about biosimilars real? Absolutely. Many big blockbusting biological drugs are losing patent over the coming years, and new and existing companies are joining the scramble to get to market first. 

The key therapeutic areas where biosimilars will have an impact are currently oncology, diabetes, IBD (gastroenterology), rheumatoid arthritis, and dermatology. But these are expanding. We are now seeing biosimilars being trialled in ophthalmology and we fully expect to see further expansion into other indications. What does this mean for the NHS? We need to ensure we get our ducks in a row (and swimming), ready for the biosimilars boom.

 

FOR MORE INFORMATION
W: www.nihr.ac.uk

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