FDA Guidance for Industry: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
Titel:
FDA Guidance for Industry: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance describes the Agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic
protein product is biosimilar to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act)