The continuing rise of biosimilars in the UK
The entrance of biosimilar competitors into a therapeutic area is an ever-present concern for pharmaceutical companies managing ageing product portfolios. On the other hand, any potential benefit to patients and clinicians of introducing additional treatment options is welcome, and many pharmaceutical companies with a stake in this market are watching developments in this space closely.
This article will focus on the evolving UK biosimilars market, including the significant impact that the Medicine and Healthcare products Regulatory Agency (MHRA) will have on the potential for market growth in the coming years.
What are biosimilars?
Biosimilars are biological medicines that are highly similar (i.e. no clinically meaningful differences) to an existing regulatory-approved product. They differ from ‘generics’, which are formulations identical to the product. Such differences may also result in varied efficacy between the originator product and the biosimilar.
Biosimilars are often treated very similarly to generics even though they have different value propositions. Where the National Institute for Health and Care Excellence (NICE) has already recommended the originator medicine, the same guidance will normally apply to a biosimilar of that originator, post-expiration of the patent1. If priced lower to account for the likely lower R&D costs of a biosimilar, they can be cost-effective alternatives, enabling commissioners to provide greater patient access to treatments.
The UK biosimilar market
The UK biosimilar market is growing due to a combination of a competitive pricing landscape, as well as a strong focus on education and best practice sharing among regional commissioners. One example of this is the growing trend for NHS England to tender biosimilars nationally and regionally2.
In the past, the majority of biosimilar cost-saving opportunity for the NHS has stemmed from the loss of exclusivity of a small number of high-value products (e.g. Mabthera, Herceptin, Enbrel, Remicade, and Humira). However, in the next 4-5 years, the European biosimilars market will experience a significant shift to a period where approximately three times the number of originator products will lose market exclusivity3. Generally, these products will be smaller in value, although blockbuster therapeutics such as Opdivo and Keytruda, for the treatment of cancer, will also form a significant part of the emerging opportunity, upon loss of market exclusivity.
Impact of MHRA
“What we see is real potential upside if the MHRA licensing regime becomes more attractive, to encourage development in areas where up to now you mightn’t have had a biosimilar medicine.” – British Biosimilar Association technical director, Paul Fleming4.
Although loss of exclusivity will dictate the time to market, the MHRA will play a significant role in shaping the post-Brexit biosimilars market and ensuring it provides more appeal than loss of market exclusively alone. Up until this point, most biosimilars have entered the UK as part of the European Medicines Agency (EMA)-centralised licensing process. Whilst companies will still continue to access the UK market through this route, companies will now be offered the choice of applying for accelerated UK market entry before going through the EMA process. The MHRA has the intention of attracting a wider variety of biosimilar products in order to increase competition across all biosimilar categories and this will be the main determinant of success of the multi-tender system currently in place. This will be carried out through the updated Marketing Authorisation Application (MAA) process with a notably reduced timeframe for the assessment of ‘high quality’ applications (150 days, compared to the previous 210 days)5.
Significantly, as stated in the MHRA consultation on the licensing of biosimilars6, the difference between the accelerated pathway proposed by the MHRA and the EMA’s 150-day accelerated assessment is that in most cases, an efficacy trial comparing the biosimilar with its originator will not be required as long as justification is provided. Additionally, no animal studies are requested as these will not be relevant for showing comparability between the biosimilar and originator. For regulatory submissions, the MHRA will also be willing to accept real-world evidence. Therefore, whilst the timelines between the MHRA and EMA regulatory approval processes are very similar, the arguably less demanding MHRA process can offer a route to market that may involve significantly lower investment on behalf of the submitting company.
What this means for industry?
The UK is on a path to grow the biosimilars market over the next 15 years. The introduction of the MHRA’s rapid approval processes, in combination with collaboration between key national players such as the NHS, NICE and the British Biosimilar Association (BBA), will aim to promote the UK as a new regional hub for R&D investments in biosimilars and a priority launch market for industry.
In the short term, this could result in more patients gaining access to potentially life-saving treatments. In the longer term however, if it erodes the profitability of products nearing the end of their lifecycle, affecting commercialisation decisions of global companies, it could also serve to threaten investment in UK R&D and ultimately, access to latest treatments for NHS patients.
If you would like to learn more about the biosimilar market or the work of Newmarket Strategy, please contact us.