Implementation of the biosimilar pathway: economic and policy issues

Seton Hall Law Rev. 2011;41(2):511-57.
No abstract available

MeSH terms

  • Biological Products / economics*
  • Biological Products / therapeutic use
  • Cost Savings
  • Diffusion of Innovation
  • Drug Approval / economics*
  • Drug Approval / legislation & jurisprudence
  • Drugs, Generic / economics*
  • Drugs, Generic / standards
  • Economic Competition
  • European Union
  • Health Care Reform
  • Health Policy*
  • Humans
  • Legislation, Drug
  • Medicaid
  • Medicare
  • Patents as Topic / legislation & jurisprudence
  • Reimbursement Mechanisms / economics*
  • Reimbursement Mechanisms / legislation & jurisprudence
  • Therapeutic Equivalency
  • United States
  • United States Food and Drug Administration

Substances

  • Biological Products
  • Drugs, Generic