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Patent Law

: Patent Docs

Clinical Trial Requirements Are Top Issue at FDA Hearings on Biosimilars

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

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By James DeGiulio -- Last week, the Food and Drug Administration began gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"). Several issues came to light during the first day of testimony, and the FDA was charged with balancing several divergent positions, the most pressing being weighing patient safety and the lowering of costs. At the center of the issue are the standards that the FDA will require for clinical testing of biosimilars. At the hearing, there was a...

Full post as published by Patent Docs on November 11, 2010 (boomark / email).

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