Biosimilars: Getting the flock to market – PMLiVE – PMLiVE


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.


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 which identifies cheaper alternatives to widely prescribed
drugs may lower the barrier to switching and nudge more prescribers to seek


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.


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.


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.


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.


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.


©2017 Life
Healthcare Communications


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