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Expert Analysis

Framing The Naming Debate For Biosimilars

Law360, New York (September 2, 2014, 11:18 AM EDT) -- The names to be ascribed to biosimilars has been the subject of much debate both in the U.S. and in Europe. Europe requires that biological products be identified by brand name instead of by their International Nonproprietary Name. An INN is a globally recognized generic name for biological, pharmaceutical and other similar products, such as the name filgrastim for the branded biologic product Neupogen. Although the European Union has set forth specific naming guidelines, the debate regarding biosimilar naming has continued internationally....

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