Description
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?
To
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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.
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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