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<tr><td><b>Comment Number: </b></td><td>537778-00013</td></tr>

<tr><td><b>Received: </b></td><td>9/30/2008 6:28:48 PM</td></tr>

<tr><td><b>Organization: </b></td><td>Biotechnology Industry Organization (BIO)</td></tr>

<tr><td><b>Commenter: </b></td><td>John Taylor</td></tr>

<tr><td><b>State: </b></td><td>DC</td></tr>

<tr><td><b>Agency: </b></td><td>Federal Trade Commission</td></tr>

<tr><td><b>Rule: </b></td><td>Emerging Health Care Competition and Consumer Issues</td></tr>

<tr><td><b>Attachments:</b></td><td><a href='537778-00013.pdf'>537778-00013.pdf</a>&nbsp<a href='http://www.adobe.com/products/acrobat/readstep2.html' target = _blank >Download Adobe Reader</a><br></td></tr></Table>

<hr><P><b>Comments:</b></p>Dear Sir/Madam, Please find attached the comments of the Biotechnology Industry Organization in response to the Federal Trade Commission's questions regarding competition provided by developing a regulatory approval pathway for follow-on biologic drugs (ref P083901). We would be pleased to provide further input or clarification of our comments, as needed. Regards, John M. Taylor, III Executive Vice President, Health Biotechnology Industry Organization</body></html>�