Specialty drugs are best defined by the full range of each product’s attributes, rather than solely by cost and route of administration.
Specialty pharmacy services are designed for a small, but growing population of patients with relatively complex and chronic diseases that require expensive and challenging drug regimens.
Complex, innovative, and high-priced specialty drugs are entering the United States health care market at a rapid rate.
With numerous specialty drug patents expiring in the next five years, manufacturers are readying new biosimilars for introduction into the market.
The total costs and utilization of specialty drugs will have a substantial impact on overall health care costs during the next decade.
While the FDA’s core mission is to protect the public heath by ensuring the safety and efficacy of drugs (among other products), the agency also makes it a priority to facilitate drug innovation.