The state of the art in the development of biosimilars

Clin Pharmacol Ther. 2012 Mar;91(3):405-17. doi: 10.1038/clpt.2011.343. Epub 2012 Feb 8.


The development of biologic therapeutics using advanced technology to copy and improve on nature's design of complex peptides, proteins, and glycoproteins has enabled the treatment of diseases in entirely new ways and brought unique and lifesaving treatments to many people. However, at least in part because of cost pressures, access to these truly amazing products has not been uniformly available; many patients do not qualify for these treatments, or the treatment is postponed until disabilities accumulate. The development of biosimilars--essentially copies of the original biologic drugs after patent expiration--allows for wider and, as important, earlier access to these agents because of their lower cost and consequently greater affordability. The development and commercialization of biosimilars can help address unmet medical needs by improving access to well-established therapeutic interventions while improving health-care affordability.

MeSH terms

  • Animals
  • Biosimilar Pharmaceuticals / standards*
  • Biotechnology / legislation & jurisprudence
  • Biotechnology / methods*
  • Cost-Benefit Analysis
  • Drug Industry / legislation & jurisprudence
  • Drug and Narcotic Control / legislation & jurisprudence*
  • Europe
  • Health Services Needs and Demand
  • Humans
  • Patents as Topic
  • United States
  • United States Food and Drug Administration


  • Biosimilar Pharmaceuticals