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New Scrip Report Provides Strategic Insight on the Burgeoning Biosimilars Market
Date:10/3/2007

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
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