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The purpose of this study was to estimate the cost of generic drug development and approval. This study develops an analytical framework for examining the expected net present value (ENPV) (i.e., the difference between the present value of expected revenues over product life and cost of product development and approval) to a generic drug developer in different size drug markets.
More than 5 million Medicare beneficiaries struggle to afford prescription medications. Among adults 65 and older, Black and Latino beneficiaries are most likely to experience affordability problems. Medicare beneficiaries with lower incomes and those under age 65 also had above-average rates of not taking needed medications due to cost.
Many stakeholders and steps are involved in the life cycle of a prescription drug as it moves from chemical synthesis and formulation through dispensing or administration to patients. The specific steps involved in prescription drug supply chains often differ depending on the type of drug, the channel of distribution, and the patient’s source of prescription drug coverage.
Drug shortages are a persistent public health problem in the United States and in other countries. Shortages can have important implications for the health care systems and pharmacies that purchase, store, and dispense drugs and for the patients who rely on the availability of drugs to treat and prevent disease.
President Biden’s Executive Order 14036, “Promoting Competition in the American Economy” (the Competition Executive Order), identifies a lack of competition as a key driver for problems across economic sectors.
This study presents the findings of a national survey of physicians about their knowledge of biosimilar biological products as well as the impact of biological product naming conventions on prescriber choice.
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