Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein-based therapeutics and monoclonal antibodies.
Dudzinski
David M
DM
D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D001688:Biological Products; D001709:Biotechnology; D001769:Blood; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000266:history / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic; D049672:History, 19th Century; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007880:Legislation, Drug; D011994:Recombinant Proteins / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
D000911:Antibodies, Monoclonal; D001688:Biological Products; D016568:Drugs, Generic; D011994:Recombinant Proteins