The passage of a biotechnology law in the US is nearing, and it is no longer certain that it will be favorable to biogenerics, also known as biosimilars. The Senate Committee on Health, Education, Labor and Pensions has voted to grant 12 years exclusivity to the products of biotechnology companies, which will keep biosimilar products off the market during this period.
Previously, talks revolved around 5-8 years exclusivity for biotechnology products. Regular generic drugs have five years exclusivity.
Biotechnology is the development of biological-based treatments. Congress is due to complete legislation on the subject this year.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) considers biogenerics to be an important growth engine.
The Senate Committee vote was 16 to 7 in favor the 12-year exclusivity. Despite the vote, this is not the end of the road for biogenerics, and the subject will come up again for a vote. Biotechnology companies are seeking a 14-year exclusivity period, while generic pharmaceutical companies, of which Teva is the world's largest, are seeking to minimize the exclusivity period. The Obama administration wants to lower healthcare costs, and supports a seven-year exclusivity period for biotechnology products.
Published by Globes [online], Israel business news - www.globes-online.com - on July 15, 2009
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