Cost Analysis of Biosimilars

Biologics are complex, protein-based drugs including insulin, monoclonal antibodies to block inflammation in rheumatoid arthritis, and a range of drugs to treat cancer, multiple sclerosis, and other serious diseases. While biologics have revolutionized treatment for many conditions, they are often expensive in terms of cost per dose. The introduction of biosimilars is expected to reduce prices, albeit to a lesser degree, comparable to small-molecule generics.

As a biosimilar is likely to be less expensive than the comparator (e.g., the reference biopharmaceutical), the assessment of the cost-effectiveness of a biosimilar depends on the relative effectiveness. If appropriately designed and powered clinical studies demonstrate equivalent effectiveness between a biosimilar and the comparator then a cost-minimization analysis identifies the least expensive medicine. If there are differences in the effectiveness of a biosimilar and the comparator, other techniques of economic evaluation need to be employed, such as cost-effectiveness analysis or cost-utility analysis. Given that there may be uncertainty surrounding the long-term safety (i.e., risk of immunogenicity and rare adverse events) and effectiveness of a biosimilar, the cost-effectiveness of a biosimilar needs to be calculated at multiple time points throughout the life cycle of the product.

  • Pharmacoeconomic Modelling of Biosimilars
  • Risk management plan (RMP) for Biosimilars
  • Cost minimal analysis
  • Cost benefit analysis
  • Cost effectiveness analysis
  • Cost utility analysis
  • Quality adjusted life years

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