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As FDA builds that disclosure infrastructure into the Purple Book, biosimilar developers will increasingly have the same pre-filing visibility into biologic patent portfolios that generic developers have always had into Orange Book listings

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References: Kecel-Gunduza S, Kocb E, Bicaka B, Kokcub Y, Ozela AE, Akyuzc S

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[DOI] [PubMed] [Google Scholar] Higgins 2002 Higgins JP, Thompson SG

Chemiluminescence using Super Signal West Pico Chemiluminescent Substrate identified all antibody-labeled proteins while protein concentration was determined by Bradford Dye Reagent [1]