WASHINGTON, Sept. 9 -- Food and Drug Administration has issued a notice called: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Industry; Availability.
The notice was published in the Federal Register on Sept. 9 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations." This guidance describes the Agency's recommendations on the design and evaluation of comparative a...