Biosimilars - the Brexit of the pharmaceutical industry?

Jenna Earl | 13th June 2016

Despite availability of biosimilars for nearly a decade, uptake in the UK is still lagging behind other EU markets, leading to the recent formation of the British Biosimilars Association (BBA) - part of the British Generic Manufacturers Association (BGMA).

Biosimilars are undoubtedly a hot topic for providers of branded biologic medicines, biosimilar suppliers themselves, and the payers, healthcare professionals and patients involved in biologic treatment. Much like the EU referendum, they feature regularly in the news - with spectators waiting anxiously, in some cases eagerly, for a change that could alter the treatment landscape for several significant therapy areas.

To understand the factors influencing the uptake of biosimilars you could apply the same principles as you would to navigating the complexities of Britain exiting the EU (Brexit).

1. Control is in the hands of the people

Britain's relationship with the EU will be decided by a referendum, placing the decision in the hands of the people. In the UK, the decision to prescribe a biosimilar is still largely down to the healthcare professional (HCP) but, if this were to change, impact on biologic markets could be dramatic.

Despite NICE recommending biosimilars ahead of branded biologics in several disease areas, this does not appear to be happening in clinical practice. The next step for governing bodies to ensure biosimilars are prioritised in the treatment pathway is substitution, replacing a branded biologic with its corresponding biosimilar at point of dispensing; a move that would result in a huge uplift in biosimilar use.

Arguably, the reason this hasn’t happened yet is that the financial gain generated by such a move does not yet outweigh the repercussions of reducing the role of the HCP in such an important decision. But with increasing pressure on the NHS to make cost savings and expect greater value from treatments, this could change in the future. 

2. Look to other markets BUT consider local circumstances

The closest we can get to understanding the impact of such a huge decision is to look at what’s happening in other countries. Many politicians who wish to stay in the EU cite Norway as a key example of what Britain faces if it were to exit in terms of tax implications. However, many argue that this would not be the case for Britain because the circumstances are so different.

The same applies when using other countries as a predictor of biosimilar use for your market. In the comparator market, is the healthcare system national or private? Does it operate tendering processes? How is reimbursement secured? What constitutes value for payers – cost savings or outcomes? In short, how easy/beneficial was it for biosimilars to be integrated in to the existing healthcare system? By answering these questions, you can determine the relevance to your local situation. 

3. Focus on Fact not Fear

For months, politicians have been debating the risks and benefits of leaving the EU. Both sides of the campaign have at times focused on manipulating an emotional response rather than providing objective facts for the public to base their decision on.

A 'fear of the unknown' is also attached to the use of biosimilars, stirring up strong emotional responses in many stakeholders. Using a treatment that does not undergo the exact same clinical trial requirements as its branded originator is bound to throw up questions, largely around the safety.

If branded biologic or biosimilar providers focus on answering these questions with clear and credible substantiation, they will undoubtedly make their argument stronger.

4. Financial implications could go one way or another

Aside from the more emotive points, there have been some fairly credible economic arguments on both sides of the EU debate. The reality, however, will depend on a sequencing of multiple events much like biosimilars.

To have the best chance of understanding and planning to deal with the implications of biosimilar uptake, pharma will need to plan for a range of scenarios (e.g. substitution, focusing on the ‘probable’ rather than just the ‘possible’).

5. Understanding and leveraging opportunities

Whatever happens in the future, there are upsides to any event. It’s important to understand what they are and to leverage them.

Uptake of biosimilars could, of course, have a negative effect on branded biologic markets, but there are also possible opportunities. BBA claim ‘the development and use of biosimilars will allow more patients to be treated for the same cost'. Branded biologics could take advantage of this potential growth if they can stabilise their position in the treatment pathway, even if it falls after first line use.

 

Much like the EU referendum, there are still a lot of unknowns regarding biosimilar use in the future. But if pharma and biosimilar providers can provide clarity for healthcare providers, and ultimately demonstrate improved outcomes for patients, everyone’s a winner.

 

For more information about biosimilars:

http://britishbiosimilars.co.uk

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