Sales of biogenerics in US, Europe to soar
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Copycat versions of expensive biotech drugs could see $16.4 billion in sales in the United States and Europe by 2011 once regulatory curbs on so-called biogenerics use are gone, a study showed on Monday.
To date, biotech drugs made using genetic engineering have been immune from generic competition, since regulators in these major markets have been slow to set clear approval rules and many are still patent-protected.
But global consulting group Frost & Sullivan said in an analysis of the sector on Monday that the outlook for biogenerics was fast improving.
“As regulatory guidelines are introduced over the next two to three years and some of the biggest biopharmaceutical blockbusters lose patent protection, the biogenerics market is expected to see exceptional growth and rapidly reach billion-dollar levels,” said Frost & Sullivan analyst Himanshu Parmar.
Generic drugmakers are keen to tap into the market by producing cheaper versions of products such as human growth hormone, transgenic insulin and erythropoietin (EPO), the “blood boosting” medicine.
Frost & Sullivan said products like these could reach markets in North America and Europe by 2006-07 and potentially generate sales of $16.39 billion by 2011.
Although no generic version of a biotech medicine has yet been approved, Europe is further ahead than the United States in the matter, having already established a legal framework, or “biosimilar”, drug applications.
Europe also has written guidelines detailing how the new rules will apply.
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