Biogenerics market set to rise as block-buster patents expire

Published: 6-Sep-2005

With patents for the earliest biopharmaceuticals to reach the market beginning to expire, the first biogeneric products are anticipated to reach the regulated markets in North America and Europe by 2006-2007.


With patents for the earliest biopharmaceuticals to reach the market beginning to expire, the first biogeneric products are anticipated to reach the regulated markets in North America and Europe by 2006-2007.

According to a new report -Strategic Analysis of the World Biogenerics Market (B613-52) - by market researcher Frost & Sullivan, products such as generic erythropoietin, recombinant human growth hormone and recombinant human interferon are anticipated to be the first product launches.

Regulatory issues have been the biggest challenge to the development of the biogenerics market but in Western Europe, the European Agency for the Evaluation of Medicinal Products (EMEA) is now accepting Market Authorisation Applications (MAA's) for biogeneric products, which show proven bio-similarity in place of clinical trials.

A reduction in clinical requirements has the potential to speed the progress of biogeneric products to market by bypassing lengthy clinical trials.

'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,' says Frost & Sullivan industry analyst Himanshu Parmar. The markets in Europe and the US have the potential to generate sales of US$16.39bn by 2011, says the report.

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