biological products / biological reference product / biologics license applications / certain competing products / particular biological product / protein products / reference product / proposed interchangeable product / interchangeable product / proposed biological product / licensed product / interchangeable biological product / biological product / particular product / certain other applications / guidance Web page / certain subsequent applications / proposed biosimilar product / chemical modifications / /
MedicalCondition
rare disease / /
Organization
office of Medical Policy / U.S. Department of Health and Human Services / Congress / office of Communication / Outreach and Development / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Division of Dockets Management / Food and Drug Administration Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / office of Communications Division of Drug Information / office of Communication / Outreach and Development Center for Biologics Evaluation / Center for Biologics Evaluation and Research / Also / Center for Biologics Evaluation and Research Food and Drug Administration / /
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act