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Sales of biogenerics in US, Europe to soar-study

September 5, 2005

LONDON (Reuters) – 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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