LONDON, October 3 /PRNewswire/ -- 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 Report.
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.
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|SOURCE Scrip Reports|
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