15 October 2018

How does switching to biosimilars effect patients?

On October 16th AbbVie’s blockbuster Humira will face competition from at least four biosimilars in EU

Unlike a generic drug which is an exact replica of another molecular product, a biosimilar is a biological medicine which is highly similar to its approved reference product. In terms of structure, efficacy, safety and immunogenicity profile biosimilars are comparable to their reference product.

AbbVie’s Humira returned WW 2017 revenue of >$18 billion, this week on 16th October its European patent expires. AbbVie has penned non-exclusive license agreement deals with Amgen, Samsung Bioepis, Sandoz and Fujifilm Kyowa Kirin Biologics.

In some EU markets, notably tender markets such as the Nordics and the UK we can expect to see fast uptake of adalimumab biosimilars eroding AbbVie’s market share. In the UK, for example the NHS has been prepping CCGs for months, providing guidance to support the switch, including a patient letter and an FAQ document. In the FAQ, the NHS employs nudge theory to encourage support stating that biosimilars are to be used “so that the money saved can be reinvested in new medicines and treatments”.

It is easy to see why health services are so keen to switch patients to the cheaper biosimilar version of commonly prescribed drugs. In a July 2018 NHS report, switching from Janssen’s Remicade to infliximab biosimilars for RA and IBD patients saved the NHS nearly £1 million over a single year.

In research that we have carried out, nudge theory techniques such as those used by NHS England are effective – as long as patients get the same care they want to ‘do their bit’ to support under-funded health services. To defend against biosimilar erosion originator companies, seek to differentiate on the value they offer. This is namely their support services, innovative, patient friendly device and established position supported by long term efficacy data. Biosimilar companies on the other hand are essentially a one trick pony – they offer a comparable clinical effect but at a much cheaper cost.

It is in this quest to maintain market share from biosimilar competitors where patients are at risk of losing out. As companies invest money to maintain prescriptions they may offer additional services which can support a patient’s disease management.

It is these value arguments which have slowed down biosimilar adoption in US due to the less restrictive direct to consumer marketing that pharma companies are allowed to engage in. In the US, only 12 biosimilars have been approved in comparison to more than 30 in EU and marketed products have struggled to gain significant market share. For example, despite two launched biosimilar competitors, Janssen’s blockbuster Remicade through a volume-driven strategy has still maintained ~94% of the molecule market share (Q2 2018 results).

Providing access to cheaper medicines, whilst encouraging innovation and providing disease management support to patients is a delicate balance. However, ultimately with increased competition, comes increased choice which can lead to increased patient empowerment.