As we enter the final chapter of 2019, Warwick Smith, Director General of the British Biosimilars Association, reflects on how the lessons garnered from adalimumab have the potential to drive future launches.

Undoubtedly one of the major developments in recent UK biosimilar history was the end of the adalimumab patent at the end of 2018 which allowed competition into the market. Not only was it a seminal moment due to the sheer scale and cost of the product, it also saw NHS England adopt a new approach to procurement: one which prioritised competition, and therefore savings to the NHS, but also crucially focused on ensuring that there were multiple suppliers, avoiding a ‘winner takes all’ approach. This assists sustainability for the industry and security of supply for patients.

Nearly a year on from competition entering the market, it’s a natural point to reflect on the success and challenges so far in light of real-world activity and experience. Our view, supported by data from the NHS, suggests that overall uptake of the biosimilars has been good, albeit there is variability between different regions. There is also now a significant amount of switching data which shows that the vast majority of existing and new patients have responded well to use of biosimilars, with low levels of re-switches taking place.

At the British Biosimilars Association, we have also undertaken our own analysis on the procurement process based on feedback from manufacturers. The overall sentiment is that the introduction of competition is demonstrably treating more patients, releasing cost savings and supporting sustainability in the NHS.

From a procurement perspective, we fully supported the NHS in piloting this new approach, given the size of opportunity and need to ensure a multi-player market. We have previously expressed reservations about the inflexibility of some aspects of medicines tendering which often places too much risk on a single manufacturer. The new approach, which centred on plurality of sustainable supply, was right and effective.

The adalimumab system, which in summary delivered greater guaranteed opportunity to secure a share of regional markets, meant that all suppliers were able to participate. Hospital tenders elsewhere have seen the winner get access with others shut out which doesn’t deliver market resilience and can lead to shortages.

Other plus points included NHS England oversight and co-ordination of contracts which has been a good mechanism to manage variability in prices offered in each region.    

Elsewhere, the communications and engagement from NHS England’s Commercial Medicines Unit was excellent in the lead-up to the original tender. We have also had a good sense that NHS England officials are willing to work with suppliers and learn from the experience of adalimumab which will help inform future similar tenders.

Another positive is that trusts are keeping some of the savings achieved so far with the rest going to CCGs. This is an important point as trusts need to see the direct value as part of the uptake process.

But there are areas where all can learn from this process to improve future tenders. Companies feel that the process was not consistent from start to finish, and that the good communication in the early stages did not carry forward to the end. We need to ensure in all cases that the right factors are taken into account in the procurement from the perspective of saving scarce NHS resources and ensuring that patients are appropriately involved, and their access to medicines enhanced.

The balance on health service gains from competition needs to be carefully monitored as well. If individual trusts aren’t seeing enough of the benefits then they won’t be incentivised to carry out patient switches.

Finally, award criteria based solely on price creates an unsustainable market. We believe that elements such as supply chain excellence – including managing shortages – should be given due consideration.

So, lots to look at and to consider the lessons for future launches. Adalimumab had many unique features but there is also much which can be translated into future biosimilar launches.    

Fine-tuning and re-shaping future processes is important in order to deliver the right level of incentives and benefits across the system, which in turn will drive uptake and savings, benefitting NHS budgets and patient access.