federal_register: 2015-10062

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2015-10062 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product." This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This guidance gives an overview of FDA's approach to determining biosimilarity. 2015-04-30 2015 4 https://www.federalregister.gov/documents/2015/04/30/2015-10062/scientific-considerations-in-demonstrating-biosimilarity-to-a-reference-product-guidance-for https://www.govinfo.gov/content/pkg/FR-2015-04-30/pdf/2015-10062.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product." This guidance is intended to assist sponsors in demonstrating...  

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