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Expert Analysis

The Contentious Biosimilar Nonproprietary Naming Debate

Law360, New York ( July 24, 2015, 11:23 AM EDT) -- In the five years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted into law, stakeholders have been hard at work fleshing out how the new product category of "biosimilars" will enter the U.S. market. Among other issues, regulators and industry alike have been focused on details of the new biosimilar approval pathway under the BPCIA's amendments to the Public Health Service Act; the practical effects of biosimilars' availability on medical professionals, insurance plans and government programs; and a myriad of marketing issues including the best way to resolve intellectual property disputes....

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