2014 Year in Review of U.S. Biosimilar Activity

Lisa Mueller, partner and Chair of the Life Sciences and Chemical Practice Groups, and Laura Opperman, Patent Scientist and member of the Intellectual Property Practice group at Michael Best & Friedrich LLP, published an article on Law360 highlighting activity taking place in respect to biosimilars in 2014.

Here is a short excerpt: “This year witnessed significant activity in the U.S. with respect to biosimilars. Highlights include issuance by the U.S. Food and Drug Administration of two new guidances, further debate over the naming of biosimilars, acceptance by the FDA of the first biosimilar application, publication of the “Purple Book” and continued legal wrangling over the so-called patent dance patent resolution provisions added to the Public Health Service Act by the Biologics Price Competition and Innovation Act of 2009…” Click here to read more of Lisa and Laura’s article.

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