The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.'' This guidance is intended to provide sponsors with an overview of analytical factors that are relevant to assessing whether a proposed product and the reference product are highly similar for the purpose of submitting a marketing application through an abbreviated licensure pathway. This guidance finalizes the draft guidance issued in February 2012.
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Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Quality Considerations in Demonstrating Biosimilarity of a Therapeuti...
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80 FR 24257
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“Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; Availability,” thefederalregister.org (April 30, 2015), https://thefederalregister.org/documents/2015-10063/guidance-for-industry-on-quality-considerations-in-demonstrating-biosimilarity-of-a-therapeutic-protein-product-to-a-ref.