However, there still remain challenges for biosimilar companies trying to gain a foothold in the market, with reticence on the part of health trusts and clinicians taking time to break down.
The UK is an example according to the British Biosimilars Association (BBA), the expert sector group of the British Generic Manufacturers Association exclusively focused on biosimilars. The BBA, whose members include manufacturers in the development and production of biosimilar medicines, says that despite use in the UK since 2006, supportive NICE guidance and NHS England backing for the appropriate use of biosimilars, there remains a low up-take in some fields, compared to a number of other European countries.
Warwick Smith, British Biosimilar Associations Director General, said: “We are seeing an increasing take-up of biosimilars in the UK but there is still some way to go. “I think one of the reasons take-up has not been as fast as it could have been is about culture. You have doctors who have been trained to prescribe a branded drug with which they are familiar and it has been an education process to persuade them to use a biosimilar instead.
“In addition, in most cases the clinical trial data relates to the original patented product and clinicians have had to understand that those data apply to the biosimilar product as well.” The association says that, given that five of the top seven biologics will lose patent by 2020, biosimilars can play a profound role in the future of healthcare in the UK by offering more choice at competitive prices. According to the BBA, competition from biosimilars can free up resources to help fund new medical breakthroughs, with competition motivating producers of patent protected medicines to develop innovative products.
Warwick said: “If you are a health trust under pressure to cut costs and you have a biosimilar that does the same job as a more expensive branded version, why would you not make the change? Indeed, NICE guidance says that if you have two drugs that do the same job a trust should go for the most cost-effective option.”
The BBA points as an example to data based on 2010 usage of human growth hormone (hGH) at The North Central London Formulary and Medicines Management Group at University College London Hospitals NHS Trust. The data suggests annual cost savings in excess of £200,000 per annum are possible from a single centre if all patients were switched from originator hGH3 to biosimilar hGH.
Warwick said: “Trusts can be assured that the regulators have ensured that the biosimilar is safe to use, although you can understand the view of patients concerned that there may be some variability in the way the biosimilar works. The point we make is that those variabilities exist in the originator as well.
“I think we are making progress and more recent biosimilar products have had much stronger take-ups than the early ones.”