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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by John Low, Ph.D. ordered by Published Date Descending.
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BPCIA 180-Day Notice Of Intent To Market A Biosimilar Is Required, Enforceable By Injunction
Apotex filed an application for an FDA license to market a biosimilar product, invoking the BPCIA's abbreviated pathway for regulatory approval of follow-on biological products that are "highly similar"...
United States
1 Sep 2016
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