The Economic Value of Biosimilars
Biosimilars are biologic products that are similar to the reference biological product in physiochemical characteristics, pharmacokinetics, and efficacy and safety. Biologic products are produced in living cells or organisms and can be a variety of biopharmaceuticals including vaccines, gene therapy, proteins, blood components, cells, or tissues. Biosimilars are not simply generic drugs of a biologic product. There are key differences between generic drugs and biosimilars. Examples of the clinical programs from the 4 FDA-approved clinical programs for biosimilar Neupogen, Remicade, Humira, and Enbrel will demonstrate a similar abbreviated pathway to approval. Economic potential for biosimilars is great in the United States. Examples from Europe will be shown to show the potential cost-savings that can be realized. Explanation on reimbursement in the United States for biosimilars, and scenarios that may give the brand or reference biologic the opportunity to competitively price their product is demonstrated in the presentation. Finally the budget impact analysis from the AMCP dossier work will be presented, to show the cost saving potential in various scenarios of switching certain percentages of a small population to the biosimilar from the reference product in a single indication (psoriasis).
Recommended CitationSimpson, Samantha, "The Economic Value of Biosimilars" (2016). Master of Science in Applied Health Economics and Outcomes Research. Presentation 10.