Category Archives: Biosimilars

Subscribe to Biosimilars RSS Feed

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

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 … Continue reading this entry

FDA Releases Draft Guidance on Biosimilars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 … Continue reading this entry