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.
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Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Scientific Considerations in Demonstrating Biosimilarity to a Referen...
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80 FR 24258
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“Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry; Availability,” thefederalregister.org (April 30, 2015), https://thefederalregister.org/documents/2015-10062/scientific-considerations-in-demonstrating-biosimilarity-to-a-reference-product-guidance-for-industry-availability.