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Data Requirements for Biosimilars (U.S. Food and Drug Administration) View |
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Regulatory Pathway for Biosimilars (HMP Education) View |
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Biosimilars: Totality of the Evidence in Biosimilar Development (U.S. Food and Drug Administration) View |
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Data Quality Expectations for Biosimilars with Case Studies (29of33) Quality – Oct. 16-17, 2019 (U.S. Food and Drug Administration) View |
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02 THE US BIOSIMILARS REGULATORY PATHWAY (AmerGastroAssn) View |
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The Basics of Biosimilars (U.S. Food and Drug Administration) View |
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(Review) Review of Biosimilar (Pmda Channel) View |
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FDA Guidance on Biosimilars (PPD) View |
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In the News... New research in T1D prevention, fast-acting biosimilar insulin approved, Lilly... (Diabetes Connections) View |
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Biosimilars: Comparative Analytical Assessment (U.S. Food and Drug Administration) View |