FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: SCIENTIFIC CONSIDERATIONS IN DEMONSTRATING BIOSIMILARITY TO A REFERENCE PRODUCT: UPDATED RECOMMENDATIONS FOR ASSESSING THE NEED FOR COMPARATIVE EFFICACY STUDIES; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Nov. 20 -- Food and Drug Administration has issued a notice called: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Nov. 20 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies." This draft ...