LONDON, Oct. 3 /CNW/ - Every successful originator company will one day
be involved in or competing with biosimilar products, making biosimilars
development a critical part of the future of biotechnology, says a new Scrip
The first generation of biopharmaceuticals manufactured using recombinant
technologies was launched in the 1980s, and patents protecting them are now
nearing expiration. As with small molecule drugs, the expiration of patents
creates an opportunity for generic biologicals to enter the market. This means
that competition from biosimilars is likely to be a challenge for every
successful biopharmaceutical product.
'Biosimilars, Biogenerics and Follow-on Biologics', a 237-page report,
provides an in-depth review of the various milestones that have led the
biosimilars arena to where it is today, as well as strategic insight for
companies in both camps: the firms that are investing their R&D efforts into
developing new biosimilars, and the innovators that are looking for ways to
counter this new challenge. And the challenge is a significant one: from sales
of $30 million in 2006, the biosimilars market is expected to be worth
$3.2 billion as soon as 2011.
The EU already has legislation in place for the approval of biosimilars
and, according to the Report, is expected to lead the way in the evolution of
the biosimilars sector, making up 45% of the world market. The situation in
the US has been more hotly contested, but this crucial market is set to follow
Europe's lead following the passing of landmark legislation by the US Senate
Health Committee in June 2007. In the same month another significant milestone
in the development of biosimilars was reached when the European medicines
agency (EMEA) recommended three biosimilar versions of recombinant
erythropoietin (EPO), a complex glycoprotein, for approval.
The Report describes how companies are currently targeting products that
are off-patent in Europe: in particular human growth hormone (hGH), EPO and
granulocyte colony-stimulating factor (G-CSF). However, it points out that
there are many more potential targets for development in areas that have so
far attracted fewer developers in Western markets.
In the Report 59 protein and 14 peptide therapeutics are discussed, all
of which achieved high-volume global sales in 2006. Half of the protein
products generated sales in excess of $500 million.
Biosimilars development also brings with it a range of scientific issues
including the critical assessment of equivalence. Important analytical
procedures available for this purpose include techniques with an established
role in protein analysis, as well as emerging techniques like nuclear magnetic
resonance spectroscopy and mass spectrometry.
The Report profiles 15 selected companies based in India, Europe, the US,
Canada and Israel, which are poised for competition in the (regulated)
biosimilars market. It also forecasts in detail the top five protein
therapeutics categories open to biosimilar competition, worth over 50% of the
total protein market in 2006.
Scrip Reports publishes an extensive range of pharmaceutical therapeutic
market reports, detailed analyses of the pharmaceutical market for specific
geographic areas, in-depth profiles of companies operating in the industry,
financial and statistical analyses, directories and other strategic reports on
the healthcare sector.
Visit http://www.scripreports.com for more information.
For further information:
For further information: Jenefer Trevena, Managing Editor, Scrip
Publishing, Tel: +44-(0)20-7017-6989, Email: firstname.lastname@example.org; To
purchase Biosimilars, Biogenerics and Follow-on Biologics, contact: Andrew
Maitland, Sales Manager, Tel: +44-(0)20-7017-6859, Email:
email@example.com and quote code: JR20003P