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« BIO Survey Shows Support for DNA-Based Patents Despite Some Reservations | Main | George Will on Innovation »

January 09, 2011

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Listed below are links to weblogs that reference Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation:

Comments

BIO asked for and got a similar letter from 4 senators: Hatch, Kerry, Hagan and Enzi.

The statute does not say what form the 12 years of exclusivity takes. If the FDA sticks with market exclusivity, then the molecule is protected for 12 years, but the test data can be made public. I'd like to hear what other people think the practical effects would be.

Thanks, Kevin. We'll see if we can get that letter.

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