federal_register: 2012-3552

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2012-3552 Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product." This draft guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting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 This draft guidance gives an overview of FDA's approach to determining biosimilarity. 2012-02-15 2012 2 https://www.federalregister.gov/documents/2012/02/15/2012-3552/draft-guidance-for-industry-on-scientific-considerations-in-demonstrating-biosimilarity-to-a https://www.govinfo.gov/content/pkg/FR-2012-02-15/pdf/2012-3552.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product." This draft guidance is intended to assist sponsors in...  

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