On February 9, 2012, the FDA issued long-awaited (draft) guidance documents on biosimilars. The three guidance documents address scientific considerations, quality considerations, and implementation of the Biologics Price Competition and Innovation Act of 2009, with a focus on therapeutic protein products. As set forth in the FDA news release, the FDA will seek public comments on the guidance documents (details on how to submit comments will be announced in an upcoming Federal Register Notice).
Category Archives: Biosimilars
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(about 47 minutes ago) - Great @BIo / GWLaw program on #patenting after #Prometheus
(about 15 hours ago) - #USPTO announces QPID program to get some post-issue fee IDS/RCEs out of the #patent RCE queue http://t.co/cUUdAlX6
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(about 9 days ago) - A look at the comments on proposed #patent trial rules. Will the #USPTO take heed? http://t.co/mLxytwTr
(about 14 days ago)