Biosimilars: Getting the flock to market

Biosimilars have now been with us for over 10 years. In case you haven't been paying attention for the past decade, a biosimilar is a highly similar version of an originator biologic agent, offering comparable efficacy and safety but with a lower acquisition cost.  

Biosimilars don't offer the same level of discount as generics because they are more costly and time-consuming to produce, but they still provide significant savings compared to the original brands. Typically they are priced at a discount of 10-30%, and some infliximab biosimilars offer reductions of up to 60%. Despite this, uptake has been slow, and the UK has lagged behind other European countries in adopting biosimilars.  

This is surprising, given the parlous finances of the NHS, and the fact that UK doctors usually love a bargain. SIx of the 10 most expensive drugs in the UK are biologics, so they are prime targets for biosimilar manufacturers. But human beings have a natural resistance to changing behaviour, even when it is to something virtually identical - as shown by our reluctance to switch banks or utility companies. The benefit of changing isn't perceived to be worth the effort of making the change, so habit and inertia prevail.  

But the move to biosimilars has finally reached a tipping point. Medical authorities including the British Gastroenterology Society and the British Society for Rheumatology have accepted the evidence that biosimilars perform as well as the originator drugs, and NICE now recommends the use of biosimilar infliximab. A new tool from openprescribing.net which identifies cheaper alternatives to widely prescribed drugs may lower the barrier to switching and nudge more prescribers to seek savings.  

Last year an audit by the Royal College of Physicians showed that Remicade (infliximab) biosimilars were "safe, effective and cheap", and should be used first line in appropriate patients because they could halve the cost of IBD treatment. This was amplified by the UK’s chief pharmaceutical officer, who stated that “Biosimilar medicines have enormous potential to deliver increased patient access, as well as savings to the NHS, which can be reinvested elsewhere.”  

And that seems to be the crucial issue.  

Initially, big pharma companies were hostile to biosimilars because they were perceived as a threat to their innovator biologics. Patents were protected and intellectual property was defended. This is hardly surprising, as billions are at stake - Remicade alone earned Johnson & Johnson over $6bn a year, while Humira is responsible for 60% of AbbVie revenues.  

But gradually, big pharma has learned that they can't beat biosimilars, so they might as well join them. Companies like Pfizer, Novartis and Amgen have bought into the biosimilar market. Currently, more than 700 biosimilars are being developed around the world, with the focus on chronic diseases and oncology. The greatest attraction, naturally, is high-revenue anti-TNF agents like MabThera (rituximab) and Humira (adalimumab), for many years the world's most valuable drug. Humira alone has more than a dozen biosimilar versions in development, having lost its US patent in 2016, and when its European patent expires in 2018 the competition is likely to be intense.  

The industry has come to recognise that biosimilars, by reducing treatment costs, can release funds for new big-ticket medicines that would otherwise be barred by their high price. So biosimilars not only increase patient access to tried and trusted biologics, they may accelerate adoption of new agents.  

Our agency created the global launch campaign for the first biosimilar monoclonal antibody. It was a fascinating experience, not least because it involved resetting some of our beliefs about marketing. Unlike most brand launches, where the emphasis is on uniqueness and innovation, the main message for a biosimilar is how well it emulates an existing product. Instead of differentiation, we need to demonstrate comparability, while still building the brand.  

The factor that drives the success of biosimilars is value. The biosimilar dividend is that more patients can get access to the high-value treatments they need. So the key to an effective launch is to develop a distinctive Value Proposition, translated into a compelling creative platform. It's important, however, to realise that value does not only reside in cost.  

Luckily, the biosimilar path has already been trodden, so new agents can slipstream the success (and learn from the failures) of early biosimilars. But with so many new entrants flocking to join, the biosimilar field is about to become very crowded. Each one has to find a unique space and own it, or they will perish. The challenge is to blend in yet still stand out.  

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