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The Science of High Similarity: Totality of Evidence, Interchangeability, and What Designation Actually Buys You 3.1 The Totality of Evidence Framework The FDA and EMA both require biosimilar applicants to demonstrate similarity through a totality of evidence approach, which is a hierarchical data package with analytical characterization as the foundation

The key levers for enhanced commercialization at AF are SBIR Technology Transition Plans (STTPs) and SBIR Technology Maturation Plans (STMPs)

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