Scientific and legal viability of follow-on protein drugs

N Engl J Med. 2008 Feb 21;358(8):843-9. doi: 10.1056/NEJMhle0706973.
No abstract available

Publication types

  • Historical Article

MeSH terms

  • Biological Products / standards
  • Drug Approval / history
  • Drug Approval / legislation & jurisprudence*
  • Drugs, Generic* / history
  • Drugs, Generic* / standards
  • Government Regulation
  • History, 20th Century
  • Humans
  • Legislation, Drug / history
  • Patents as Topic / legislation & jurisprudence
  • Recombinant Proteins* / standards
  • United States
  • United States Food and Drug Administration

Substances

  • Biological Products
  • Drugs, Generic
  • Recombinant Proteins