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).
Open season: Branded industry gets
in on the act It may have taken a while, but the world’s major pharmaceutical
originators have recognised the potential for biosimilars. A number have
disclosed their intentions and/or announced clinical trials in recent months.
For example, in February 2013, Amgen announced plans to launch a portfolio of
six new biosimilars beginning in 2017: adalimumab, infliximab, bevacizumab,
trastuzumab, rituximab and cetuximab. Four of these projects form part of the
company’s development agreement with Actavis. In June 2012, Merck KGaA and Dr
Reddy's Laboratories announced a partnership to co-develop a portfolio of
biosimilar compounds in oncology, primarily focused on monoclonal antibodies.
Pfizer has been openly active in generics and biosimilars for some time. The
company previously had a collaborative deal with Biocon for its insulin
products, although this deal was concluded in March 2012. In May 2013, Pfizer
began a Phase I trial with an infliximab biosimilar, PF-06438179. Many smaller
biosimilar developers have the ambition but not the resources. The increasing
interest from big Pharma will bring a welcome boost of expertise and funding to
research and partnering.
Contact
M/s Sheela
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