Biosimilar Opportunities In An Evolving Market
The
long awaited promise of biosimilars takes another step to fulfilment
with the first approval in Europe of high-value second generation
products. But what products can be expected to follow, who is developing
them and what are the hot prospects?
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Biosimilars: another milestone passed
At
the end of June 2013, the European Medicines Agency’s Committee for
Medical Products for Human Use issued a positive opinion for the first
biosimilar version of Johnson & Johnson’s infliximab for the
treatment of rheumatoid arthritis, inflammatory bowel disease and plaque
psoriasis. For the two successful applicants, Celltrion and Hospira,
this development passes a significant milestone for the whole biosimilar
sector as the products are the first monoclonal antibody (mAb)
therapies to reach a positive opinion following review via the EMA
biosimilars regulatory pathway. This is an important event which heralds
a new era of lower-cost biological therapies in Europe.
For
J&J and its partners, the news is less welcome. Already under
pressure from branded competitors in the TNF inhibitor market, it is no
surprise that both developer and biosimilar companies will be assessing
what share they may secure of its US$6.13 billion revenues.
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The tip of a US$41 billion iceberg
While
significant for J&J, infliximab is just the tip of the iceberg when
it comes to the potential for biosimilars. In terms of revenue, six of
the top ten pharmaceutical therapies are biological products, which have
been targeted by biosimilar developers: Abbvie’s Humira (adalimumab),
Roche’s MabThera (rituximab), Herceptin (trastuzumab) and Avastin
(bevacizumab), Sanofi’s Lantus (insulin glargine), and Johnson &
Johnson’s Remicade (infliximab). These products had combined global
sales of US$41.4 billion in 2012. Also of significant importance to
biosimilar developers, with sales of US$4.2 billion in 2012 is Amgen’s
Enbrel (etanercept).
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