For instance, specialty drugs in the Medicare Part D program are only defined by cost – currently $670/month (2018) – and indexed annually. There is no single agreed-upon definition, so sometimes specialty drug will only mean high-cost. Specialty drug: A drug that is costly, requires special supply chain features (such as freezing or cold storage), typically indicated for a small group of patients, and where the patients may need special case management services.
Physician-administered drugs: Any kind of drug that cannot typically be self-administered. Retail drugs: Any kind of drug typically available at a pharmacy counter. These drugs are not currently considered to be identical to the original product (because of the nature of manufacturing with live products), but are considered to be therapeutic alternatives.
#GENERIC TERMINOLOGY FOR PULPMOTION GENERIC TERMINOLOGY LICENSE#
Licensed under an Abbreviated New Drug Application by the FDA.īiologic: A therapeutic drug or a vaccine, made from living organisms - human, animal, yeast, or microorganisms - licensed under a Biologic License Application by the FDA.īiosimilar: Competitors to the first-in-class biologic product that has an expired patent. Generics are considered identical to the brand product. Generic drug: Competitors to a branded product that has an expired patent. It is licensed under a New Drug Application by the US Food and Drug Administration (FDA). It is protected by a patent or has an expired patent. A brand can be an innovator (first-in-class) or not. Drug Product Termsīrand product: Branded products are not generic drugs or products. Below is a glossary of terms commonly used by players in the drug research, regulation, manufacturing, distribution, and purchasing worlds.
If you’re working to control the cost of prescription drugs, you need to know the lingo used by the pharmaceutical industry.
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