Specialty drugs (aka specialty pharmaceuticals)

High-cost/high-touch medicines, frequently biologics, that require strict manufacturing processes, special handling (supply-chain distribution and drug administration) and used to treat highly complex or rare chronic conditions and diseases. Examples of specialty drugs include factor products for hemophiliac patients, oncolytic (reengineered virus that penetrates cancer cells) and oncology medicines for cancer patients, treatments for some types of muscular dystrophy, and emerging gene-based therapies used in diseases caused by genetic mutations.

Many specialty drug manufacturers advertised their drugs as “personalized medicines” because the drug targets specific biomarkers present in an individual’s blood; however, industry regulators and associations suggested manufacturers refrain from using “personalized medicine,” which indicates a medication created specifically for an individual—such as compounded medicines—to “precision medicine” or “targeted therapy.”