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7 Common Characteristics of a Specialty Drug

The definition of a specialty drug continues to evolve as the specialty drug pipeline advances and expands. Specialty pharmaceuticals (specialty drugs) are best defined by the full range of each product’s attributes, rather than solely by cost and route of administration. Specialty drugs sometimes require special handling and administration (injection or infusion), and patients using a specialty drug may need careful oversight from a health care provider, in tandem with a specialty pharmacist, who can watch for side effects and ensure that the medication is working as intended.

While there is no agreed-upon definition for specialty pharmaceuticals, there are common characteristics of a specialty drug including:

  1. Involves complex treatment regimens that require ongoing clinical monitoring and patient education
  2. Has special handling, storage, or delivery requirements
  3. Is generally biologically derived and available in injectable, infusion, or oral form
  4. Has increased potential for limited or exclusive product availability and distribution
  5. Is dispensed to treat individuals with less common and rare diseases
  6. Treats diseases or conditions marked by long-term or severe symptoms, side effects, or increased fatality
  7. Has higher costs than traditional small molecule drugs

Given these parameters, pharmaceutical manufacturers must ensure that the specialty pharmacy can meet or even exceed the standards of their product’s specific special handling requirements such as overnight shipping or same-day delivery, ultra-cold chain storage (-80°C) requirements, and the ability to deliver to multiple sites of care. This standard should apply whether it be a rare disease, cell, or gene therapy.

In our digital guide, Rare Diseases, Gene, and Cell Therapies: Specialty Pharmacy Considerations, we cover what is most important when selecting a specialty pharmacy to partner with for your next drug launch.

If you have immediate questions, you can also connect with an Orsini representative at any time.