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- W2529129628 abstract "T term “scientific justification” is used 15 times in the FDA Guidance for Industry entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” Approaches to biosimilar development requiring justification include minor protein alterations, duration of immunogenicity studies, and the types of clinical trials to be conducted based on available sponsor and innovator data. Frequent mention of scientific justification suggests that, in the absence of mechanisms to establish the identical character of a biosimilar and innovator, the quality of existing data will impact clinical trial requirements. Openness to scientific discussion creates an opportunity to review the specific evidentiary needs of each biosimilar with the Agency and to tailor development programs accordingly. It also creates an implicit partnership between sponsors and the FDA in developing scientifically sound approaches to biosimilar approval. Meeting this partnership challenge requires effective scientific dialog with the FDA." @default.
- W2529129628 created "2016-10-14" @default.
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- W2529129628 date "2013-07-15" @default.
- W2529129628 modified "2023-09-24" @default.
- W2529129628 title "The role of scientific justification in the nascent US biosimilars approval pathway" @default.
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