FDA must address debate over naming of biologics, biosimilars

07/2/2014 | Genetic Engineering & Biotechnology News

The FDA could approve the first ever follow-on biologic as early as next year, but it will have to address the debate on whether the same nonproprietary names should be used by reference biologics and their biosimilars and interchangeable biologics, attorneys Thomas Lavery and William James write. The many citizen petitions and responses filed by the Pharmaceutical Research and Manufacturers of America and other groups reflect the issue's importance to the drug industry, they write. The decision will likely affect access and investment to follow-on biologics, they write.

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