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Category Archives: Biosimilars

A Look At Abbott’s Citizen Petition Against The Biologics Price Competition And Innovation Act

Posted in Biosimilars

I am pleased to introduce Taylor Corbitt as a new author for PharmaPatentsBlog. Taylor is an associate in our Chemical, Biotechnology & Pharmaceutical Practice and works out of our Chicago office. ~Courtenay Brinckerhoff

When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the “Biologics Act”) may have breathed a sigh of relief. However, the Biologics Act is not out of the woods, because Abbott recently filed a Citizen Petition with the FDA, seeking to block its implementation of the law as unconstitutional.Continue reading this entry

FDA Releases Draft Guidance on Biosimilars

Posted in Biosimilars

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).

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