Table 2.

Typical features of state legislation related to biologic medications and substitution of biosimilars according to the NCSL as of 2015

NCSL: state laws and legislation related to biologic medications and substitution of biosimilars
Any biological product under consideration for substitution must first be approved as “interchangeable” for substitution by US FDA.
The prescriber (such as a physician, an oncologist, and a physician assistant) would be able to prevent substitution by stating “dispense as written” or “brand medically necessary”.
The prescriber must be notified of any allowable substitution made at a pharmacy. (This would allow a physician to assess and compare the patient experience).
The individual patient must be notified that a substitute or switch has been made. In some cases, state law would require patient consent before any such switch is made.
The pharmacist and the physician must retain records of substituted biologic medications.
The pharmacist would not be liable in any way for the dispensing of an interchangeable biological product if it complied with the listed state law provisions.
The state must maintain a public list of permissible interchangeable products.

Note: Data from Jelkmann.²⁵

Abbreviations: NCSL, National Conference of State Legislatures; US FDA, US Food and Drug Administration.